| LYMPHLAND |
| LYMPHEDEMA CLINICAL TRIALS 2008 |
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| http://clinicaltrials.gov/ct2/results?recr=Open&cond=%22Lymphedema%22
Trial of Decongestive Lymphatic Therapy for Lymphedema in Women With Breast Cancer "DELTA STUDY" This study is currently recruiting participants. Verified by Ontario Clinical Oncology Group (OCOG), October 2007 Sponsors and Collaborators: Ontario Clinical Oncology Group (OCOG) Canadian Breast Cancer Research Alliance Information provided by: Ontario Clinical Oncology Group (OCOG) ClinicalTrials.gov Identifier: NCT00201890 Purpose The purpose of this study is to evaluate the efficacy, safety and impact on quality of life of decongestive lymphatic therapy (DLT) in women who have completed treatment for breast cancer and present with lymphedema. This is a multicentre trial enrolling 100 patients randomized to receive conservative care for arm lymphedema (Canadian Guidelines) with or without decongestive lymphatic therapy performed by a professional who has received training and certification in the technique of lymphatic draining massage. Duration: One year after the last patient is randomized. Condition Intervention Phase Breast Cancer Lymphedema Procedure: Decongestive Lymphatic Therapy Phase III Genetics Home Reference related topics: Lymphatic Diseases breast cancer MedlinePlus related topics: Breast Cancer Lymphatic Diseases U.S. FDA Resources Study Type: Interventional Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study Official Title: DELTA - A Randomized Trial of Decongestive Lymphatic Therapy for Lymphedema in Women With Breast Cancer Further study details as provided by Ontario Clinical Oncology Group (OCOG): Primary Outcome Measures: Percent reduction in excess arm volume as calculated from circumferential arm measurements [ Time Frame: at 6 weeks ] Secondary Outcome Measures: Measurement of arm function [ Time Frame: Midtreatment,6,12 24,52 weeks ] Quality of life [ Time Frame: Midtreament, 6 12,24,52 weeks ] Estimated Enrollment: 100 Study Start Date: March 2003 Estimated Study Completion Date: July 2008 Detailed Description: Randomized patients receive either standard of care or standard of care plus DLT (five massage sessions per week for 4 consecutive weeks). Primary evaluation of all patients is recorded six weeks after randomization by measuring the affected limb and comparing with the unaffected one. There is an extended follow-up of one year. Eligibility Ages Eligible for Study: 18 Years and older Genders Eligible for Study: Female Accepts Healthy Volunteers: No Criteria Inclusion Criteria: Women with a histological diagnosis of breast cancer experiencing edema in the ipsilateral arm such that there is a minimum 15% increase in arm volume over the opposite arm. Patients must have completed all primary and adjuvant treatments (surgery, chemotherapy, radiotherapy) prior to randomization. This is to ensure that scheduling difficulties with daily treatments do not arise. Patients may be currently taking tamoxifen or similar hormonal treatment. Exclusion Criteria: Clinical or radiological evidence of active disease, either local or metastatic. History of contralateral cancer, axillary surgery, radiation or bilateral arm edema. (Edema volume will be taken as the increase in volume compared to the unaffected arm; previous therapy in the opposite arm will reduce the accuracy of measuring excess volume related to lymphedema.) Previous surgery involving nodal dissection or radiotherapy to other major node-bearing areas in the body such as the mediastinum or pelvis. Disruption of lymphatic flow in these potentially alternate routes may be compromised by such interventions. Patients are eligible after a simple hysterectomy (+/- oophorectomy). Previously undergone massage therapy for arm edema, or has used compression sleeve within the last month. Serious non-malignant disease, such as renal or cardiac failure, which would preclude daily treatment and follow up. Patients for whom massage is contraindicated, such as those with untreated infections or thromboses in the affected arm. Unable to commence therapy within 7 days of randomization. Psychiatric or addictive disorders which preclude obtaining informed consent or adherence to the protocol. Contacts and Locations Please refer to this study by its ClinicalTrials.gov identifier: NCT00201890 Contacts Contact: Betsy A MacKinnon, MSc. 905 527 2299 ext 42606 mackinn@mcMaster.ca Contact: Sharon Nason 905 527 2299 ext 42622 Locations Canada, New Brunswick Dr. Leon Richard Oncology Centre Recruiting Moncton, New Brunswick, Canada, E1C 8X3 Contact: Linda LeBlanc, MD Contact: Joanne LeBlanc-Chiasson 506 862 4263 Principal Investigator: Linda LeBlanc, MD Sub-Investigator: Andree Lirette, MD Sub-Investigator: Fernando Rojas, MD Saint John Regional Hospital Recruiting Saint John, New Brunswick, Canada, E2L 4L2 Contact: Margot Burnell, MD Contact: Sharon Turnell Canada, Newfoundland and Labrador Dr. H. Bliss Murphy Cancer Centre Recruiting St. John's, Newfoundland and Labrador, Canada, A1B 3V6 Contact: Dawne Putt 709 777 7557 dawne.putt@easternhealth.ca Contact: Martina Reddick 709 777 8713 martina.reddick@easternhealth.ca Canada, Ontario Juravinski Cancer Centre Recruiting Hamilton, Ontario, Canada, L8V 5C2 Contact: Ian Dayes, MD 905 387 9495 ext 64704 ian.dayes@hrcc.on.ca Contact: Jennifer Wiernikowski, MD 905 387 9495 ext 64148 Principal Investigator: Ian Dayes, MD Sub-Investigator: Tim Whelan, MD Sub-Investigator: Jennifer Wiernikowski, RN Sub-Investigator: Donna Lue Reise, RN Thunder Bay Regional Health Science Centre, Regional Cancer Centre Recruiting Thunder Bay, Ontario, Canada, P7B 6V4 Contact: Katheen Simpson, MD 807 684 7234 Contact: Cindy Sinnott 807 684 7234 Principal Investigator: Kathleen Simpson, MD Sub-Investigator: Margaret Lyn Anthes, MD Sunnybrook Regional Cancer Centre Recruiting Toronto, Ontario, Canada, M4N 3M5 Contact: Kathleen Pritchard, MD 416 480 4616 Principal Investigator: Kathleen Pritchard, MD Princess Margaret Hospital Recruiting Toronto, Ontario, Canada, M5G 2M9 Contact: Lee Manchul, MD 416 946 2127 Principal Investigator: Lee Manchul, MD London Regional Cancer Centre Recruiting London, Ontario, Canada, N6A 4L6 Contact: David P D'Souza, MD 519 685 8650 Principal Investigator: David P D'Souza, MD Sub-Investigator: Lyn Kligman, MD Sub-Investigator: Barbara Osinga, RMT Sponsors and Collaborators Ontario Clinical Oncology Group (OCOG) Canadian Breast Cancer Research Alliance Investigators Study Director: Ian Dayes, MD Ontario Clinical Oncology Group Principal Investigator: Tim Whelan, MD Hamilton Health Sciences Principal Investigator: Jim Julian, M. Math Hamilton Health Sciences Principal Investigator: Lyn Kligman, RN London Regional Cancer Centre Principal Investigator: Kathy Pritchard, MD Sunnybrook Regional Cancer Centre More Information Study ID Numbers: CBCRA- 013260 First Received: September 12, 2005 Last Updated: October 19, 2007 ClinicalTrials.gov Identifier: NCT00201890 Health Authority: Canada: Ethics Review Committee Keywords provided by Ontario Clinical Oncology Group (OCOG): Breast Cancer Lymphedema Treatment Massage Randomized DLT therapy Quality of Life Decongestive Therapy Breast Cancer related Lymphedema Study placed in the following topic categories: Lymphedema Lymphatic Diseases Skin Diseases Connective Tissue Diseases Quality of Life Breast Neoplasms Breast Diseases Additional relevant MeSH terms: Skin and Connective Tissue Diseases Neoplasms Hemic and Lymphatic Diseases Neoplasms by Site Lymphedema ClinicalTrials.gov processed this record on February 29, 2008 -------------------------------------------------------------------------------------- Aquatic Exercise Study for Breast Cancer Patients With Lymphedema This study is currently recruiting participants. Verified by Baylor Research Institute, July 2007 Sponsored by: Baylor Research Institute Information provided by: Baylor Research Institute ClinicalTrials.gov Identifier: NCT00498771 Purpose The purpose of this study is to determine what effects aquatic exercise has on participants with Lymphedema. Condition Intervention Lymphedema Behavioral: Exercise Genetics Home Reference related topics: Lymphatic Diseases MedlinePlus related topics: Lymphatic Diseases U.S. FDA Resources Study Type: Interventional Study Design: Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study Official Title: Aquatic Exercise Study for Breast Cancer Patients With Lymphedema Further study details as provided by Baylor Research Institute: Estimated Enrollment: 100 Study Start Date: July 2006 Detailed Description: This pilot study will examine the effectiveness of aquatic exercise in reducing Lymphedema. The study is designed for breast cancer patients who have developed Lymphedema following cancer treatment. Potential study participants should have explored conventional treatments such as decongestive therapy and lymph drainage massage before joining the study. There are two groups that the participants may choose from until enrollment for the group has reached its capacity. The active arm of the study will attend 12 one-hour aquatic exercise classes at the Tom Landry Fitness Center. There is no cost to the participants and classes will be held in an indoor heated pool. Both the active arm and the control group (not attending aquatic exercise classes) will have 3 measurement assessments, which will compare the circumference and volumetric measurement of both arms, as well as height, weight and body mass index (BMI). Comparison of the circumference and volumetric measurements of the affected limb will be made prior to, midpoint and at completion of the 12 class program. Body mass index will be taken during the same time frames. Both groups will also fill out questionnaires. Quality of life surveys taken at baseline, week 6, month 6 and 12 will be compared. Exercise History Questionnaires will be completed at 6 and 12 month intervals and annually for five years. Eligibility Ages Eligible for Study: 21 Years to 90 Years Genders Eligible for Study: Both Accepts Healthy Volunteers: No Criteria Inclusion Criteria: Breast cancer patients with Lymphedema Patients must have received standard Lymphedema treatment (Complete Decongestive Therapy) prior to participating in the study. Patients undergoing treatment will require written permission from their physician Complete an assessment by a licensed physical therapist before beginning the exercise program Patients must sign a consent form to participate Exclusion Criteria: Patients undergoing treatment without physician’s written permission Patients with health problems that contraindicate exercise Patients are not eligible if the physical therapy assessment identifies a contraindication to participation Contacts and Locations Please refer to this study by its ClinicalTrials.gov identifier: NCT00498771 Contacts Contact: Suzette Clark 214-820-8299 SuzetteC@baylorhealth.edu Locations United States, Texas Baylor Sammons Breast Center Recruiting Dallas, Texas, United States, 75246 Contact: Suzette Clark 214-820-8299 SuzetteC@baylorhealth.edu Principal Investigator: Michael D. Grant, M.D. Sponsors and Collaborators Baylor Research Institute Investigators Principal Investigator: Michael Grant, M.D. Baylor Sammons Breast Center More Information Study ID Numbers: Baylor IRB #006-116 First Received: July 9, 2007 Last Updated: July 9, 2007 ClinicalTrials.gov Identifier: NCT00498771 Health Authority: United States: Institutional Review Board Keywords provided by Baylor Research Institute: Lymphedema Aquatic Exercise Breast Cancer Study placed in the following topic categories: Lymphedema Lymphatic Diseases Skin Diseases Connective Tissue Diseases Breast Neoplasms Breast Diseases Additional relevant MeSH terms: Skin and Connective Tissue Diseases Neoplasms Hemic and Lymphatic Diseases Neoplasms by Site Lymphedema ClinicalTrials.gov processed this record on February 29, 2008 ------------------------------------------------------------------------ Safety Study of Bevacizumab to Treat Women With a History of Breast Cancer and Suffering From Upper Extremity Lymphedema This study is not yet open for participant recruitment. Verified by Premiere Oncology of Arizona, April 2006 Sponsors and Collaborators: Premiere Oncology of Arizona Genentech Information provided by: Premiere Oncology of Arizona ClinicalTrials.gov Identifier: NCT00318513 Purpose The purpose of this study is to determine the safety and side effects of bevacizumab in subjects with lymphedema who will initially receive bevacizumab alone and then in combination with standard manual lymphatic drainage (MLD) and combined decongestive therapy (CDT). This study will help to determine the dose of bevacizumab to be used in future studies of subjects with lymphedema. Condition Intervention Phase Lymphedema Drug: Bevacizumab Phase I Genetics Home Reference related topics: Lymphatic Diseases MedlinePlus related topics: Lymphatic Diseases ChemIDplus related topics: Bevacizumab U.S. FDA Resources Study Type: Interventional Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study Official Title: Phase I Study Evaluating the Safety of Bevacizumab in Women With a History of Breast Cancer Suffering From Moderate to Severe Upper Extremity Lymphedema Further study details as provided by Premiere Oncology of Arizona: Estimated Enrollment: 35 Detailed Description: Lymphedema occurs with varying frequency in patients with cancer but approximately 10-15% of all breast cancer patients will develop lymphedema following breast cancer treatment. Lymphedema in breast cancer patients following axillary lymph node dissection is caused by the interruption of the axillary lymphatic system by surgery or radiation therapy, which causes an accumulation of fluid in the subcutaneous tissue of the arm, with decreased distensibility of tissue around the joints and increased weight of the extremity. The primary current therapy employed involves complete decongestive therapy (CDT) which encompasses the use of manual lymphatic drainage (MLD) and compression bandaging (CB) to the affected limb. The specific contribution of the vascular system to the development of lymphedema is unclear. Vascular permeability is a complex process which is primarily controlled by the interaction of the ligand vascular endothelial growth factor (VEGF). As a result of the understanding of the biology of VEGF and the anecdotal appreciation of women with lymphedema who have noted improvement in their lymphedema while on VEGF inhibitor therapy, it is hypothesized that the reduction in vascular permeability resulting from the use of a VEGF inhibitor either alone or in conjunction with standard decongestive lymphedema therapy may significantly improve the outcome for patients with this post-operative complication. Bevacizumab is a recombinant humanized monoclonal antibody directed against VEGF. Bevacizumab blocks the development of new blood vessels in cancer and it is approved by the FDA for the treatment of colon cancer in combination with chemotherapy. While bevacizumab has been administered to thousands of patients with cancer, there is only limited information about the use of bevacizumab in subjects without active cancer. This study will evaluate the safety profile of escalating doses of bevacizumab administered intravenously alone for 4 weeks followed by 4 weeks of therapy in combination with manual lymph drainage (MLD) and compression bandaging (CB) to patients with moderate to severe unilateral upper extremity lymphedema due to prior breast cancer therapy. Eligibility Genders Eligible for Study: Female Accepts Healthy Volunteers: No Criteria Inclusion Criteria: Women with a history of breast cancer status post (s/p) prior surgical resection (i.e., either lumpectomy and radiation, modified radical mastectomy or radical mastectomy) with lymphedema defined as a difference in limb volume of at least 500 ml by perometric assessment Lymphedema may be newly diagnosed or previously treated as long as it is Stage I (pitting) or II (fibrosis) at the time of study entry. No known evidence of recurrent or active metastatic breast cancer No prior chemotherapy within 6 months of study entry and has recovered to grade 1 or less from the toxicity of all prior chemotherapy or radiation therapy (with the exception of alopecia); ongoing anti-estrogen therapy for post-menopausal survivors is permissible. Normal end organ function defined as: serum creatinine < 1.5 mg/dl or a calculated creatinine clearance > 50 ml/min; SGOT and SGPT < 2.5 X upper limit of normal (ULN); total bilirubin < 1.5 X ULN; absolute neutrophil count (ANC) > 1,500 cells/µl; hemoglobin > 10 g/dl (without transfusions); platelet count > 100,000/µl; serum albumin within normal limits (WNL). Exclusion Criteria: Stage III (lymphostatic elephantiasis) lymphedema Clinical evidence of bilateral lymphedema. Those patients who have undergone bilateral breast cancer surgery or prophylactic mastectomy on the non-cancerous breast will be excluded. Any prior history of deep venous thrombosis (DVT) or pulmonary embolus (with the exception of prior line-related thrombotic events) or myocardial infarction (MI), cerebrovascular accident (CVA) or any other arterial thromboembolic event (i.e., transient ischemic attack [TIA], reversible ischemic neurologic deficit [RIND], history of angina pectoris, clinically significant peripheral vascular disease with claudication, etc.) Patients with problems with wound healing (e.g., diabetic ulcers), gastrointestinal fistula Patients receiving therapeutic anti-coagulation including full dose aspirin or non-steroidal anti-inflammatory agents known to inhibit platelet function (low dose coumadin for port prophylaxis and low dose aspirin are allowed) Untreated hypertension with a baseline systolic blood pressure (SBP) of > 150 mmHg or a diastolic blood pressure (DBP) >100 mmHg will be excluded (stable treated hypertension with values less than those noted will be eligible). A history of infectious complications of the involved arm or those with any contraindication to MLD + CB [e.g., congestive heart failure (CHF), DVT, acute or chronic renal failure] will be excluded. Women with a history of CHF [New York Heart Association (NYHA) Class II or greater] will be excluded. Pregnant or breast-feeding Unwilling to use an appropriate form of barrier contraception for the duration of the study and for three months following the last dose of bevacizumab Those patients who are actively undergoing MLD and/or CB at the time of study entry and for up to 4 weeks prior to entry Unable to provide written informed consent or to comply with study procedures Baseline urine protein : creatinine ratio > 1.0 Known evidence of a bleeding diathesis or coagulopathy Contacts and Locations Please refer to this study by its ClinicalTrials.gov identifier: NCT00318513 Contacts Contact: Michael S Gordon, MD 480-860-5000 mgordon@premiereoncology.com Locations United States, Arizona Premiere Oncology of Arizona Not yet recruiting Scottsdale, Arizona, United States, 85260 Principal Investigator: Michael S Gordon, MD Sponsors and Collaborators Premiere Oncology of Arizona Genentech Investigators Principal Investigator: Michael S Gordon, MD Premiere Oncology of Arizona More Information Publications: Velanovich V, Szymanski W. 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Lack of effect of coumarin in women with lymphedema after treatment for breast cancer. N Engl J Med. 1999 Feb 4;340(5):346-50. Ueda Y, Yamagishi T, Samata K, Ikeya H, Hirayama N, Okazaki T, Nishihara S, Arai K, Yamaguchi S, Shibuya M, Nakaike S, Tanaka M. A novel low molecular weight VEGF receptor-binding antagonist, VGA1102, inhibits the function of VEGF and in vivo tumor growth. Cancer Chemother Pharmacol. 2004 Jul;54(1):16-24. Epub 2004 Apr 3. Checkley D, Tessier JJ, Kendrew J, Waterton JC, Wedge SR. Use of dynamic contrast-enhanced MRI to evaluate acute treatment with ZD6474, a VEGF signalling inhibitor, in PC-3 prostate tumours. Br J Cancer. 2003 Nov 17;89(10):1889-95. Morgan B, Thomas AL, Drevs J, Hennig J, Buchert M, Jivan A, Horsfield MA, Mross K, Ball HA, Lee L, Mietlowski W, Fuxuis S, Unger C, O'Byrne K, Henry A, Cherryman GR, Laurent D, Dugan M, Marme D, Steward WP. 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Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer. N Engl J Med. 2004 Jun 3;350(23):2335-42. Yang JC, Haworth L, Sherry RM, Hwu P, Schwartzentruber DJ, Topalian SL, Steinberg SM, Chen HX, Rosenberg SA. A randomized trial of bevacizumab, an anti-vascular endothelial growth factor antibody, for metastatic renal cancer. N Engl J Med. 2003 Jul 31;349(5):427-34. Ostendorf T, Kunter U, Eitner F, Loos A, Regele H, Kerjaschki D, Henninger DD, Janjic N, Floege J. VEGF(165) mediates glomerular endothelial repair. J Clin Invest. 1999 Oct;104(7):913-23. Shen BQ, Lee DY, Gerber HP, Keyt BA, Ferrara N, Zioncheck TF. Homologous up-regulation of KDR/Flk-1 receptor expression by vascular endothelial growth factor in vitro. J Biol Chem. 1998 Nov 6;273(45):29979-85. Dvorak HF, Nagy JA, Feng D, Brown LF, Dvorak AM. Vascular permeability factor/vascular endothelial growth factor and the significance of microvascular hyperpermeability in angiogenesis. 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Study ID Numbers: AVF3251s First Received: April 24, 2006 Last Updated: May 9, 2006 ClinicalTrials.gov Identifier: NCT00318513 Health Authority: United States: Food and Drug Administration Keywords provided by Premiere Oncology of Arizona: breast cancer lymphedema extremity women Study placed in the following topic categories: Lymphedema Lymphatic Diseases Skin Diseases Stress, Psychological Connective Tissue Diseases Stress Breast Neoplasms Bevacizumab Breast Diseases Additional relevant MeSH terms: Lymphedema Skin and Connective Tissue Diseases Hemic and Lymphatic Diseases Antineoplastic Agents Growth Substances Physiological Effects of Drugs Angiogenesis Inhibitors Pharmacologic Actions Behavioral Symptoms Neoplasms Neoplasms by Site Therapeutic Uses Angiogenesis Modulating Agents Growth Inhibitors ClinicalTrials.gov processed this record on February 29, 2008 ---------------------------------------------------------------------------------- Predictors of Lymphedema Following Breast Cancer Surgery This study is currently recruiting participants. Verified by Park Nicollet Institute, April 2007 Sponsors and Collaborators: Park Nicollet Institute U.S. Army Medical Research and Materiel Command Information provided by: Park Nicollet Institute ClinicalTrials.gov Identifier: NCT00202046 Purpose The purpose of this study evaluate which factors play a role in lymphedema development among women who have had axillary surgery for breast cancer. Potential risk factors for women who have developed lymphedema will be compared to risk factors among women who have not developed lymphedema after breast cancer surgery. Condition Breast Cancer Lymphedema Genetics Home Reference related topics: Lymphatic Diseases breast cancer MedlinePlus related topics: Breast Cancer Lymphatic Diseases U.S. FDA Resources Study Type: Observational Study Design: Natural History, Cross-Sectional, Case Control, Prospective Study Official Title: Predictors of Lymphedema Following Breast Cancer Surgery Further study details as provided by Park Nicollet Institute: Estimated Enrollment: 200 Study Start Date: January 2003 Estimated Study Completion Date: September 2007 Detailed Description: Surgery for breast cancer includes removal of the breast tumor along with the axillary lymph nodes. The status of these nodes helps clinicians determine prognosis and guides treatment decisions. Unfortunately, a relatively common side effect following axillary lymph node dissection is upper-extremity lymphedema. The purpose of this study is to identify risk factors for lymphedema among women who have had axillary surgery for breast cancer. Specific aims include identifying risk factors for lymphedema and comparing quality of life (QOL) ratings for women who have and do not have lymphedema. A case-control study will be conducted with enrollment of 200 participants. Cases will be identified at their lymphedema consult in the physical therapy centers. Using the oncology registry, controls will include patients who have had breast cancer surgery and have not developed lymphedema. The severity of lymphedema and interference with daily life will be assessed with the Measure of Arm Symptom Survey (MASS), a patient-completed survey, and QOL will be collected with the SF-36. Treatment risk factors including previous surgery, radiotherapy and chemotherapy will be obtained from oncology registry data. This study will determine which factors play a role in lymphedema development. Eligibility Ages Eligible for Study: 18 Years and older Genders Eligible for Study: Female Accepts Healthy Volunteers: Yes Criteria Inclusion Criteria: Clinical diagnosis of lymphedema Axillary node surgery by sentinel node or axillary node dissection No known metastatic disease in the axilla Able and willing to give informed consent Contacts and Locations Please refer to this study by its ClinicalTrials.gov identifier: NCT00202046 Contacts Contact: Karen K Swenson, RN, MS, PhDc 952-993-6071 swensk@parknicollet.com Contact: Elaine Bell, RN, BSN 952-993-6705 elaine.bell@parknicollet.com Locations United States, Minnesota Fairview University Recruiting Minneapolis, Minnesota, United States, 55455 Contact: Juliette Gay, RN, BS 612-625-2956 Principal Investigator: Janice Post-White, RN, PhD Park Nicollet Institute Recruiting St. Louis Park, Minnesota, United States, 55416 Contact: Karen K Swenson, RN, MS, PhD(c) 952-993-6071 swensk@parknicollet.com Contact: Tracy L Messing, RN, BSE 952-993-6723 messit@parknicollet.com Principal Investigator: Karen K Swenson, RN, MS, PhDc North Memorial Medical Center Recruiting Minneapolis, Minnesota, United States, 55422 Contact: Jean Pupkes, RN, MS 763-520-5211 jean.pupkes@northmemorial.com Principal Investigator: Jean Pupkes, RN, MS Sponsors and Collaborators Park Nicollet Institute U.S. Army Medical Research and Materiel Command Investigators Principal Investigator: Karen K Swenson, RN, MS, PhDc Park Nicollet Institute More Information Study ID Numbers: 1728-03-B, DAMD17-03-0738 First Received: September 13, 2005 Last Updated: April 25, 2007 ClinicalTrials.gov Identifier: NCT00202046 Health Authority: United States: Federal Government Keywords provided by Park Nicollet Institute: Breast cancer Lymphedema Quality of life Study placed in the following topic categories: Lymphedema Lymphatic Diseases Skin Diseases Connective Tissue Diseases Quality of Life Breast Neoplasms Breast Diseases Additional relevant MeSH terms: Skin and Connective Tissue Diseases Neoplasms Hemic and Lymphatic Diseases Neoplasms by Site Lymphedema ClinicalTrials.gov processed this record on February 29, 2008 ---------------------------------------------------------------------------------- The Impact of Lymphedema on Overall and Local Functioning This study is currently recruiting participants. Verified by University of California, San Francisco, May 2007 Sponsors and Collaborators: University of California, San Francisco National Institutes of Health (NIH) Information provided by: University of California, San Francisco ClinicalTrials.gov Identifier: NCT00501436 Purpose Lymphedema is a significant problem for breast cancer survivors. This is a two-part research study. The first part consists of tests which will help us understand the impact that lymphedema (swelling in the arm, hand, or breast) related to breast cancer and its treatments has to local (hand and arm) and overall functioning, and quality of life. As little is known about the genetic (inherited) factors that may increase a person’s likelihood of having lymphedema (swelling), the second (OPTIONAL) part of this study involves banking human biological specimens for future research which will help explore what these genetic factors are, so that health care providers may be able to identify women who have an increased likelihood of developing lymphedema and possibly prevent the symptom or decrease the severity. Condition Lymphedema Breast Cancer Quality of Life Genetics Home Reference related topics: Lymphatic Diseases breast cancer MedlinePlus related topics: Breast Cancer Lymphatic Diseases U.S. FDA Resources Study Type: Observational Study Design: Natural History, Cross-Sectional, Defined Population, Retrospective Study Official Title: The Impact of Lymphedema on Overall and Local Functioning Further study details as provided by University of California, San Francisco: Estimated Enrollment: 300 Study Start Date: February 2007 Estimated Study Completion Date: June 2008 Detailed Description: The overall hypothesis of this study is that lymphedema detrimentally affects functioning of the affected upper extremity and results in reduction in local and overall functioning in breast cancer survivors.Standardized laboratory measurements of upper extremity function and overall physical functioning will be used to document the impact of lymphedema.Functioning measures will be related to the degree of lymphedema, which will be measured using bioelectric impedance spectroscopy (BIS), specifically, multiple frequency bioelectric impedance analysis (MFBIA) - a technique that provides a measure of limb and segmental intracellular and extracellular water. Eligibility Ages Eligible for Study: 18 Years and older Genders Eligible for Study: Female Accepts Healthy Volunteers: No Criteria Inclusion Criteria: women 18 years and older completed active treatment for breast cancer at least 6 months previously mentally and physically able Exclusion Criteria: Bilateral breast cancer had bilateral or contralateral breast surgery current infection or lymphangitis in the affected arm prior neuromuscular conditions that would affect local or overall functioning recurrence of breast cancer pre-existing lymphedema medical contraindications to BIS testing contraindications to exercise testing body weight exceeding maximum weight limit for treadmill machine Contacts and Locations Please refer to this study by its ClinicalTrials.gov identifier: NCT00501436 Contacts Contact: Josephine Wong, MD 415-476-6975 Locations United States, California CTSI Clinical Research Center, 12/F, Moffitt Hospital, 505 Parnassus Avenue Recruiting San Francisco, California, United States, 94143 Principal Investigator: Marylin Dodd, RN, PhD Sponsors and Collaborators University of California, San Francisco National Institutes of Health (NIH) Investigators Principal Investigator: Marylin Dodd, RN, PhD University of California, San Francisco More Information Study ID Numbers: 1 R21 NR010282-01, CHR# H452-29674-01C, CCRC# 43-13 First Received: July 12, 2007 Last Updated: July 12, 2007 ClinicalTrials.gov Identifier: NCT00501436 Health Authority: United States: Institutional Review Board Keywords provided by University of California, San Francisco: Lymphedema Breast Cancer Survivors local functioning Overall functioning Quality of Life Bioelectrical Impedance Spectroscopy (BIS) Multiple Frequency Bioelectrical Impedance Analysis (MFBIA) Study placed in the following topic categories: Lymphedema Lymphatic Diseases Skin Diseases Connective Tissue Diseases Quality of Life Breast Neoplasms Breast Diseases Additional relevant MeSH terms: Skin and Connective Tissue Diseases Neoplasms Hemic and Lymphatic Diseases Neoplasms by Site Lymphedema ClinicalTrials.gov processed this record on February 29, 2008 ----------------------------------------------------------------------------------- A Pilot Study of VEGF Inhibition in Patients With Lymphedema Following Breast Cancer Treatment This study is currently recruiting participants. Verified by Indiana University, November 2007 Sponsored by: Indiana University School of Medicine Information provided by: Indiana University ClinicalTrials.gov Identifier: NCT00393497 Purpose The purpose of this study is to evaluate the effectiveness of bevacizumab in women with lymphedema as a result of previous treatment for breast cancer. Condition Intervention Phase Breast Cancer Lymphedema Drug: bevacizumab Phase I Genetics Home Reference related topics: Lymphatic Diseases breast cancer MedlinePlus related topics: Breast Cancer Lymphatic Diseases ChemIDplus related topics: Bevacizumab U.S. FDA Resources Study Type: Interventional Study Design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study Official Title: A Pilot Study of VEGF Inhibition in Patients With Lymphedema Following Breast Cancer Treatment Further study details as provided by Indiana University: Primary Outcome Measures: Arm Volume [ Time Frame: baseline, Day 1, Day 22, q 6wks, termination ] [ Designated as safety issue: No ] The affected and unaffected arm measured at five defined points: [ Time Frame: baseline, Day 1, Day 22, q 6wks, termination ] [ Designated as safety issue: No ] each hand just distal to the thumb [ Time Frame: baseline, Day 1, Day 22, q 6wks, termination ] [ Designated as safety issue: No ] each wrist at its narrowest point [ Time Frame: baseline, Day 1, Day 22, q 6wks, termination ] [ Designated as safety issue: No ] each arm 30 cm proximal to the tip of the middle finger [ Time Frame: baseline, Day 1, Day 22, q 6wks, termination ] [ Designated as safety issue: No ] each arm 40 cm proximal to the tip of the middle finger [ Time Frame: baseline, Day 1, Day 22, q 6wks, termination ] [ Designated as safety issue: No ] each arm 50 cm proximal to the tip of the middle finger (if possible before the axilla is reached.) [ Time Frame: baseline, Day 1, Day 22, q 6wks, termination ] [ Designated as safety issue: No ] The volume of each arm will be calculated from these measurements using the Casley Smith method29. Treatment will be considered efficacious if there is a greater than or equal to 25% decrease in excess arm volume (affected arm volume minus unaffected arm [ Time Frame: baseline, Day 1, Day 22, q 6wks, termination ] [ Designated as safety issue: No ] Patients will initially be treated for 42 days (6 weeks). [ Time Frame: Day 1-42 ] [ Designated as safety issue: No ] Estimated Enrollment: 15 Study Start Date: April 2007 Estimated Study Completion Date: April 2007 Intervention Details: Drug: bevacizumab Bevacizumab 15 mg/kg IV every 21 days Detailed Description: The primary objective of this study is: • To assess the degree of improvement in arm edema as measured by changes in arm volume in patients with ipsilateral lymphedema The secondary objectives of this study are: To assess the degree of improvement in arm edema as measured by changes in arm interstitial fluid pressure (IFP) To assess the degree of improvement in arm edema as measured by changes in extracellular fluid (ECF) volume based on bioelectrical impedance analysis (BIA) by lymphometer To assess the safety and tolerability of VEGF inhibition in this patient population To assess the clinical benefit in patients with ipsilateral lymphedema treated with vascular endothelial growth factor (VEGF) inhibition by evaluating patient responses to a quality of life questionnaire (FACT-B+4 lymphedema questions) To determine the impact of VEGF inhibition on circulating VEGF levels in patients with lymphedema Eligibility Ages Eligible for Study: 18 Years and older Genders Eligible for Study: Female Accepts Healthy Volunteers: No Criteria Inclusion Criteria: Have unilateral lymphedema of the ipsilateral arm attributed to prior surgical treatment or radiation therapy for breast cancer that is severe enough to warrant therapy in the opinion of the subject and treating physician. All subjects must have greater than a 3 cm total difference in arm circumference between the affected and unaffected arm measured at five defined points: each hand just distal to the thumb each wrist at its narrowest point each arm 30 cm proximal to the tip of the middle finger each arm 40 cm proximal to the tip of the middle finger each arm 50 cm proximal to the tip of the middle finger (if possible before the axilla is reached.) Be at least 18 years of age Have adequate organ function as specified below: AST and ALT less than or equal to 2.0 times ULN Total bilirubin less than or equal to 1.5 mg/dL Serum creatinine less than or equal to 1.5 mg/dL Urine protein:creatinine ratio < 1.0* LVEF > institutional limits of normal by MUGA or ECHO PT INR < 1.5; PTT < 1.5 x normal Absolute neutrophil count greater than or equal to 1000/mm3 Platelets greater than or equal to 100,000/mm3 Agree to use effective contraceptive methods during the course of the study if the subject has child-producing potential Have an ECOG performance status of 0 or 1 Exclusion Criteria: Subjects must not be pregnant, lactating, or refuse to use appropriate birth control Subjects must not have an active infection requiring parenteral or oral antibiotics Subjects must not have clinically significant cardiovascular or cerebrovascular disease, including: Any history of: Cerebrovascular disease including TIA, stroke or subarachnoid hemorrhage Ischemic bowel Hypertensive crisis or hypertensive encephalopathy Within the last 12 months Myocardial infarction Unstable angina New York Heart Association (NYHA) grade II or greater congestive heart failure Grade II or greater peripheral vascular disease DVT or PE Active at study entry Uncontrolled hypertension defined as SBP > 150 or DBP > 100 Uncontrolled or clinically significant arrhythmia. Subjects may not have locally recurrent or metastatic disease Subjects may not require concurrent therapeutic anticoagulation. (NOTE: Prophylactic doses of coumadin to maintain patency of a vascular access device is allowed). In addition, subjects with a bleeding diathesis are excluded. Subjects may not have had major surgery within 4 weeks of starting protocol therapy (NOTE: Placement of a vascular access device is not considered major surgery) Subjects may not have received radiation therapy, chemotherapy or trastuzumab within the past 6 weeks (NOTE: Concurrent adjuvant hormonal therapy is allowed.) Subjects may not have altered the physical therapy regimen for lymphedema within the past month Subjects may not have an indwelling venous device in the ipsilateral arm Subjects may not have bilateral lymphedema Subjects may not have a non-healing wound, ulcer or bone fracture. Subjects may not have a known hypersensitivity to any component of Bevacizumab Contacts and Locations Please refer to this study by its ClinicalTrials.gov identifier: NCT00393497 Contacts Contact: LaTrice Vaughn, RN 317-278-3730 lgvaughn@iupui.edu Contact: Anita Rush-Taylor, RN 317-278-6797 arushtay@iupui.edu Locations United States, Indiana Indiana University Cancer Center Recruiting Indianapolis, Indiana, United States, 46202 Contact: LaTrice Vaughn, RN 317-278-3730 lgvaughn@iupui.edu Contact: Anita Rush-Taylor, RN 317-278-6797 arushtay@iupui.edu Principal Investigator: Kathy Miller, MD Sponsors and Collaborators Indiana University School of Medicine Investigators Principal Investigator: Kathy Miller, MD Indiana University More Information search Breast Cancer Responsible Party: Indiana University Cancer Center ( Kathy Miller, MD/ Principal Investigator ) Study ID Numbers: 0606-24, IUCRO-0162 First Received: October 26, 2006 Last Updated: November 29, 2007 ClinicalTrials.gov Identifier: NCT00393497 Health Authority: United States: Food and Drug Administration Keywords provided by Indiana University: Breast Cancer lymphedema Study placed in the following topic categories: Lymphedema Lymphatic Diseases Skin Diseases Connective Tissue Diseases Breast Neoplasms Bevacizumab Breast Diseases Additional relevant MeSH terms: Lymphedema Skin and Connective Tissue Diseases Hemic and Lymphatic Diseases Antineoplastic Agents Growth Substances Physiological Effects of Drugs Angiogenesis Inhibitors Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Angiogenesis Modulating Agents Growth Inhibitors ClinicalTrials.gov processed this record on February 29, 2008 ----------------------------------------------------------------------------------- Education With or Without Exercise and Counseling in Preventing Lymphedema in Women With Stage I, Stage II, or Stage III Breast Cancer Who Are Undergoing Axillary Lymph Node Dissection This study is currently recruiting participants. Verified by National Cancer Institute (NCI), February 2008 Sponsors and Collaborators: Cancer and Leukemia Group B National Cancer Institute (NCI) Information provided by: National Cancer Institute (NCI) ClinicalTrials.gov Identifier: NCT00376597 Purpose RATIONALE: A personalized exercise program, counseling, and education materials may be more effective than education materials alone in preventing lymphedema in women with breast cancer who are undergoing axillary lymph node dissection. PURPOSE: This randomized clinical trial is studying how well education with or without exercise and counseling works in preventing lymphedema in women with stage I, stage II, or stage III breast cancer who are undergoing axillary lymph node dissection. Condition Intervention Breast Cancer Lymphedema Perioperative/Postoperative Complications Procedure: conventional surgery Procedure: counseling Procedure: educational intervention Procedure: exercise intervention Procedure: management of therapy complications Procedure: quality-of-life assessment Genetics Home Reference related topics: Lymphatic Diseases breast cancer MedlinePlus related topics: Breast Cancer Lymphatic Diseases U.S. FDA Resources Study Type: Interventional Study Design: Other, Randomized, Active Control Official Title: A Randomized Study to Prevent Lymphedema in Women Treated for Breast Cancer Further study details as provided by National Cancer Institute (NCI): Primary Outcome Measures: Lymphedema incidence (percentage of women who remain free from the presence of lymphedema for 18 months) [ Designated as safety issue: No ] Secondary Outcome Measures: Severity of lymphedema as assessed by changes in arm circumference [ Designated as safety issue: No ] Agreement between patients' self-report of swelling and the extent of circumferential measurement difference between the treated side and the contralateral arm [ Designated as safety issue: No ] Health-related quality of life as assessed by Functional Assessment of Cancer Therapy-Breast (FACT-B) +4 score [ Designated as safety issue: No ] Adherence to lymphedema prevention exercises, lymphedema knowledge, range of motion, and arm strength [ Designated as safety issue: No ] Estimated Enrollment: 560 Study Start Date: June 2006 Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure) Detailed Description: OBJECTIVES: Primary Determine the efficacy of a comprehensive program of tailored exercise, lymphedema prevention patient education, and counseling vs lymphedema prevention patient education only in reducing the incidence of lymphedema in women with stage I-III breast cancer who are undergoing axillary lymph node dissection. Secondary Compare the severity of lymphedema, in terms of changes in arm circumference at the site of greatest difference as a continuous variable, in patients undergoing these interventions. Assess the agreement between patients' self-report of swelling (mild, moderate, or severe) and the extent of circumferential measurement difference between the treated side and the contralateral arm at the site of greatest difference (< 0.5 inches vs = 0.5 and < 2 inches vs = 2 inches). Compare the health-related quality of life of these patients. Characterize adherence to lymphedema prevention exercises, lymphedema knowledge, range of motion, and arm strength. OUTLINE: This is a randomized, controlled, multicenter study where the unit of randomization is the participating center. Participating centers are stratified according to the annual number of patients with stage I-III breast cancer who undergo axillary node dissection at the center (small vs moderate vs large number of patients) and are randomized to 1 of 2 arms. Patients are thus randomized to 1 of 2 intervention arms based on the identified participating center. All patients complete questionnaires prior to surgery regarding lymphedema knowledge, health-related quality of life, fear of cancer recurrence, self-efficacy, body-image, self-report of range of motion, arm circumference, and demographics. Patients then undergo surgery, which must include axillary node dissection. Arm I: Six weeks after surgery, patients receive a brief initial post-operative care session describing lymphedema risk and prevention through oral instruction and written materials. Patients complete physical assessments and questionnaires at 6 weeks and at 6, 12, and 18 months. Patients are also contacted by telephone at 9 and 15 months. Arm II: Patients receive lymphedema education and complete physical assessments and questionnaires as in arm I. Patients also complete a personalized exercise regimen and receive a 15-minute video that reinforces information and exercises. PROJECTED ACCRUAL: A total of 560 patients will be accrued for this study. Eligibility Ages Eligible for Study: 18 Years and older Genders Eligible for Study: Female Accepts Healthy Volunteers: No Criteria DISEASE CHARACTERISTICS: Diagnosis of breast cancer Newly diagnosed disease Stage I-III disease No diagnosed lymphedema Arm circumference = 17 inches Scheduled to undergo axillary node dissection with = 10 nodes removed No sentinel axillary node dissection only Hormone receptor status not specified PATIENT CHARACTERISTICS: Female Menopausal status not specified No documented cardiac conduction disturbances, unstable angina, dementia, or any other chronic disease that, in the opinion of the investigator, significantly reduces mortality over the next 2 years May not be currently homebound or dependent upon a walker or wheelchair for mobility Able to participate in a mild exercise program No prior history of carcinoma in situ, lobular carcinoma in situ, ductal carcinoma in situ, or invasive breast cancer Patients with a history of other invasive malignancies are eligible as long as they have completed treatment and are 5 years post-diagnosis Patients with basal cell and squamous cell carcinoma of the skin are eligible PRIOR CONCURRENT THERAPY: See Disease Characteristics No prior double mastectomy with axillary node dissection involving both arms May be enrolled on other treatment trials except surgery trials where one treatment arm involves full axillary node dissection Any type of radiotherapy to the breast or axilla allowed Neoadjuvant treatment for this cancer allowed Contacts and Locations Please refer to this study by its ClinicalTrials.gov identifier: NCT00376597 Show 32 Study Locations Sponsors and Collaborators Cancer and Leukemia Group B National Cancer Institute (NCI) Investigators Study Chair: Electra D. Paskett, PhD Arthur G. James Cancer Hospital & Richard J. Solove Research Institute More Information Clinical trial summary from the National Cancer Institute's PDQ® database Featured trial article Study ID Numbers: CDR0000494652, CALGB-70305 First Received: September 13, 2006 Last Updated: February 27, 2008 ClinicalTrials.gov Identifier: NCT00376597 Health Authority: Unspecified Keywords provided by National Cancer Institute (NCI): lymphedema perioperative/postoperative complications stage I breast cancer stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer Study placed in the following topic categories: Lymphedema Signs and Symptoms Lymphatic Diseases Pathologic Processes Skin Diseases Postoperative Complications Connective Tissue Diseases Breast Neoplasms Breast Diseases Additional relevant MeSH terms: Skin and Connective Tissue Diseases Neoplasms Hemic and Lymphatic Diseases Neoplasms by Site Lymphedema Pathological Conditions, Signs and Symptoms ClinicalTrials.gov processed this record on February 29, 2008 ----------------------------------------------------------------------------------------- Identification of a Screening Tool and Treatment of Lymphedema Secondary to the Management of Breast Cancer Study This study is currently recruiting participants. Verified by Sidney Kimmel Comprehensive Cancer Center, April 2007 Sponsored by: Sidney Kimmel Comprehensive Cancer Center Information provided by: Sidney Kimmel Comprehensive Cancer Center ClinicalTrials.gov Identifier: NCT00282529 Purpose The proposed research is designed to establish lymphedema incidence rates for a varied population of breast cancer patients. Patients with breast preservation, mastectomy, sentinel lymph node biopsy, axillary dissection and radiation therapy will be included with the goal of determining the impact that each of these treatments has on development of lymphedema. Establishing incidence in these populations is crucial to the remainder of the study. We conduct a two phase study. The first phase will use arm measurements, a symptom survey (The Lymphedema and Breast Questionnaire), a functional survey (Disability of the Arm, Shoulder, and Hand Questionnaire), and operative and pathology information to create a simple screening tool to predict the development of lymphedema. Currently, lymphedema is only diagnosed after arm swelling develops. The goal of the screening tool is to identify those patients at significantly increased risk for development of lymphedema as compared to the general population of breast cancer survivors. Phase 2 of the study will test a lymphedema prevention strategy in a high risk population. The goal of this phase is to reduce the incidence of lymphedema in those patients that have undergone an axillary node dissection with radiation therapy by using a combination of education, a compression sleeve and decongestive exercises. If prevention is successful, the development of a screening tool becomes even more important to identify those patients that should undergo a prevention regimen. Condition Intervention Breast Cancer Lymphedema Device: High Risk Lymphedema Education and Device Intervention Genetics Home Reference related topics: Lymphatic Diseases breast cancer MedlinePlus related topics: Breast Cancer Lymphatic Diseases U.S. FDA Resources Study Type: Interventional Study Design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study Official Title: Identification of a Screening Tool and Treatment of Lymphedema Secondary to the Management of Breast Cancer Study Further study details as provided by Sidney Kimmel Comprehensive Cancer Center: Primary Outcome Measures: Bilateral arm measurements, Lymphedema and Breast Cancer Questionnaire, Disability of the Arm and Shoulder and Hand(DASH)Questionnaire Secondary Outcome Measures: Standard lymphedema risk reduction education, Lymphedema prevention Estimated Enrollment: 400 Study Start Date: January 2006 Detailed Description: Background: Lymphedema has varied definitions, all based on limb volume changes. None incorporates limb volume changes, symptoms, and functional deficits. We will determine the incidence of lymphedema in breast cancer patients and the impact of breast conserving therapy, radiation therapy, sentinel lymph node biopsy, and axillary node dissection. The impact of lymphedema can be evaluated in a number of ways; 1) The Lymphedema and Breast Cancer Questionnaire (LBCQ) identifies symptoms that are unique to patients with lymphedema and 2) The Disability of the Arm, Hand, and Shoulder (DASH) survey will be used to determine the functional impact of lymphedema. Objective/Hypothesis: Our hypotheses are: 1) Local therapies for breast cancer result in different lymphedema rates depending on the combination of therapies used. 2) A simple screening tool that incorporates symptoms, limb volume measurements, and tumor staging and treatment modalities can predict those patients that will develop lymphedema. 3) Functional impairment of the arm is severe in patients with lymphedema. 4) Prevention of lymphedema in a high risk population is possible with education, a compression sleeve, and decongestive exercise. Specific Aims: 1) Evaluate patients both pre-operatively and at specific time intervals post-operatively to establish the incidence of lymphedema in sentinel lymph node biopsy and axillary dissection groups. 2) Create a simple screening tool using arm measurements, symptoms identified by the LBCQ, and treatment and staging information to identify patients that should go on to further testing and treatment. 3) Utilize the DASH survey to measure the extent of disability from lymphedema and surgical treatment. 4) Conduct a randomized trial of lymphedema prevention in a high-risk breast cancer population. Study Design: This proposal will be conducted in two phases. Phase 1 will accomplish Specific Aim 1, 2, and 3. Patients with newly diagnosed breast cancer awaiting definitive surgery, will be enrolled pre-operatively and undergo arm measurements and complete the LBCQ and the DASH surveys. These same study procedures will be completed at 1, 3, 6, 12, 18, and 24 months postoperative. Documentation collected during the study will include: demographic information; co-morbid conditions; operative and pathology reports; and use of adjuvant therapies such as chemotherapy, hormonal therapy, and radiation therapy. Incidence rates of lymphedema and the impact of extent of surgery and radiation therapy will be determined. We will also use this information to develop a simple screening tool to identify patients that will develop lymphedema prior to the development of significant limb volume changes. Specific Aim 4 is Phase 2 of the proposal. A high risk population (those that have an axillary node dissection and radiation therapy) will be randomized to standard education versus standard education, compression sleeve, and exercise. The effectiveness of prevention to reduce incidence and severity of lymphedema and the impact on symptoms and functional impairment will be determined. This work will move toward a new paradigm of lymphedema management with a simple screening tool to identify high risk patients before significant swelling occurs and investigate prevention strategies to decrease the incidence of lymphedema. Cancer Relevance: Lymphedema is a feared complication of breast cancer treatment. Currently it is recognized and treated only after development of significant limb volume changes when it is symptomatic and difficult to treat. Documentation of the impact of local therapies on the development of lymphedema will allow clinicians to make more informed decisions regarding risk benefit ratios of each of our local therapies. Development of a screening tool will allow us to identify high risk populations. Ideally, the high risk population will be identified and an effective prevention strategy implemented. Phase one of this study will help to answer the questions regarding incidence and create a screening tool and phase two will allow the evaluation of a prevention strategy. Eligibility Ages Eligible for Study: 18 Years and older Genders Eligible for Study: Both Accepts Healthy Volunteers: No Criteria Inclusion Criteria: Age of 18 years or older, biopsy proven breast cancer with no known metastatic cancer, surgical management of breast cancer with node evaluation to be completed at Johns Hopkins Hospital, ability to speak and read English, willing and able to continue follow-up at Johns Hopkins Avon foundation Breast Center - Exclusion Criteria: Known psychiatric illness, unwillingness to be followed for two years, functional arm deficits, prior radiation therapy to the breast or axilla, any prior diagnosis of cancer except basal cell cancer - Contacts and Locations Please refer to this study by its ClinicalTrials.gov identifier: NCT00282529 Contacts Contact: Ilze Sikorski, RN 410-955-7797 isikors1@jhmi.edu Contact: David Dierker 410-502-8757 ddierke1@jhmi.edu Locations United States, Maryland Avon Breasts Center, Johns Hopkins Medical Institutions Recruiting Baltimore,, Maryland, United States, 21287 Contact: Mary Ellen Haisfield-Wolfe, RN, MS 410-502-3844 mhaisfield-wolfe@jhmi.edu Sub-Investigator: Ted Tsangaris, M. D. Principal Investigator: Lisa Jacobs, M.D. Sub-Investigator: Julie Lange, M. D. Sub-Investigator: Nita Ahuja, M. D. Sponsors and Collaborators Sidney Kimmel Comprehensive Cancer Center Investigators Principal Investigator: Lisa Jacobs, M.D. Johns Hopkins Medical Institutions, Department of Surgery More Information Study ID Numbers: J05101 First Received: January 24, 2006 Last Updated: April 23, 2007 ClinicalTrials.gov Identifier: NCT00282529 Health Authority: United States: Institutional Review Board Keywords provided by Sidney Kimmel Comprehensive Cancer Center: lymphedema, screening, treatment Study placed in the following topic categories: Lymphedema Lymphatic Diseases Skin Diseases Connective Tissue Diseases Neoplasm Metastasis Breast Neoplasms Breast Diseases Additional relevant MeSH terms: Skin and Connective Tissue Diseases Neoplasms Hemic and Lymphatic Diseases Neoplasms by Site Lymphedema ClinicalTrials.gov processed this record on February 29, 2008 ---------------------------------------------------------------------------------- Flexitouch® Home Maintenance Therapy or Standard Home Maintenance Therapy in Treating Patients With Lower-Extremity Lymphedema Caused by Treatment for Cervical Cancer, Vulvar Cancer, or Endometrial Cancer This study is currently recruiting participants. Verified by National Cancer Institute (NCI), December 2007 Sponsors and Collaborators: Gynecologic Oncology Group National Cancer Institute (NCI) Information provided by: National Cancer Institute (NCI) ClinicalTrials.gov Identifier: NCT00577317 Purpose RATIONALE: Flexitouch® home maintenance therapy may lessen lower-extremity lymphedema caused by treatment for gynecologic cancer. It is not yet known whether the Flexitouch® system is more effective than standard home maintenance therapy in treating lymphedema. PURPOSE: This randomized phase III trial is studying Flexitouch® home maintenance therapy to see how well it works compared with standard home maintenance therapy in treating patients with lower-extremity lymphedema caused by treatment for cervical cancer, vulvar cancer, or endometrial cancer. Condition Intervention Phase Cervical Cancer Endometrial Cancer Lymphedema Vulvar Cancer Procedure: management of therapy complications Procedure: quality-of-life assessment Phase III Genetics Home Reference related topics: Lymphatic Diseases MedlinePlus related topics: Cervical Cancer Lymphatic Diseases Uterine Cancer Vulvar Cancer U.S. FDA Resources Study Type: Interventional Study Design: Supportive Care, Randomized, Single Blind Official Title: A Prospective Randomized Single Blind Phase III Trial Comparing Flexitouch® Home Maintenance Therapy to Standard Home Maintenance Therapy for Lower Extremity Lymphedema Resulting From Treatment of Gynecologic Malignancy Further study details as provided by National Cancer Institute (NCI): Primary Outcome Measures: Comparison of effectiveness of Flexitouch® vs standard home lymphedema therapy Lower-extremity volumes for both unaffected and affected legs Secondary Outcome Measures: Quality of life (QOL) and functional status Correlation of changes in limb volume to changes in QOL Pain in affected limb Deep-vein thrombosis Cellulitis Need for unscheduled visits at the patients' lymphedema clinic Estimated Enrollment: 262 Study Start Date: January 2008 Detailed Description: OBJECTIVES: Primary Compare the effectiveness of the Flexitouch® System to standard home lymphedema therapy (Manual Lymphatic Drainage) in the management of lower-extremity lymphedema in women with a history of cervical, vulvar, or endometrial cancer. Secondary Compare the quality of life (QOL) and functional status between patients using the Flexitouch® System and those following standard home lymphedema treatment (Manual Lymphatic Drainage) programs in the management of lower-extremity lymphedema. Tertiary Correlate changes in limb volume to changes in QOL outcomes in order to produce an estimate of a clinically meaningful change in limb volume for use in future studies. OUTLINE: This is a multicenter study. Patients are stratified according to site of cancer (cervical vs vulvar vs endometrial) and stage of lymphedema at diagnosis. Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive standard home maintenance therapy and perform self-manual lymphatic drainage once daily for 60 minutes for 24 weeks. Arm II: Patients receive Flexitouch® home maintenance therapy once daily for 60 minutes for 24 weeks. Patients complete quality of life questionnaires at baseline, every 8 weeks during treatment, and at completion of study treatment. Eligibility Ages Eligible for Study: 18 Years and older Genders Eligible for Study: Female Accepts Healthy Volunteers: No Criteria DISEASE CHARACTERISTICS: Diagnosis of unilateral lower-extremity lymphedema as a result of surgery, chemotherapy, and/or radiation therapy for cervical, vulvar, or endometrial cancer Prior to acute clinic therapy, the affected limb edema must have been greater than stage I and must have had at least a 10% excess volume over the unaffected limb No clinic therapy for lower-extremity lymphedema for 6 months prior to the start of the patient's acute clinic therapy Must be within 3 years from the completion of therapy for original gynecologic cancer diagnosis At the time of completion of acute clinic therapy, patients must have reached their nadir limb volume for two consecutive measurements each 7-10 days apart No known active or recurrent cancer PATIENT CHARACTERISTICS: GOG performance status 0-2 Not pregnant No history of peripheral vascular disease (venous or arterial), pulmonary edema, congestive heart failure, or chronic renal disease No current diagnosis of deep-vein thrombosis or phlebitis in the affected limb No open wound(s) or active infection of the affected limb No history of chronic lower-extremity lymphoma that predates cancer diagnosis No poorly controlled asthma PRIOR CONCURRENT THERAPY: See Disease Characteristics More than 3 months since prior cancer treatment Contacts and Locations Please refer to this study by its ClinicalTrials.gov identifier: NCT00577317 Locations United States, Minnesota University of Minnesota Cancer Center Recruiting Minneapolis, Minnesota, United States, 55455 Contact: Clinical Trials Office - University of Minnesota Cancer Center 612-624-2620 Sponsors and Collaborators Gynecologic Oncology Group National Cancer Institute (NCI) Investigators Study Chair: Levi S. Downs, MD University of Minnesota More Information Clinical trial summary from the National Cancer Institute's PDQ® database Study ID Numbers: CDR0000579834, GOG-0236 First Received: December 19, 2007 Last Updated: January 8, 2008 ClinicalTrials.gov Identifier: NCT00577317 Health Authority: Unspecified Keywords provided by National Cancer Institute (NCI): lymphedema stage 0 cervical cancer stage IA cervical cancer stage IB cervical cancer stage IIA cervical cancer stage IIB cervical cancer stage III cervical cancer stage IVA cervical cancer stage IVB cervical cancer stage 0 uterine corpus cancer stage I uterine corpus cancer stage II uterine corpus cancer stage III uterine corpus cancer stage IV uterine corpus cancer stage 0 vulvar cancer stage I vulvar cancer stage II vulvar cancer stage III vulvar cancer stage IV vulvar cancer Study placed in the following topic categories: Pregnancy Complications Genital Neoplasms, Female Uterine Diseases Urogenital Neoplasms Lymphedema Uterine Cervical Neoplasms Genital Diseases, Female Lymphatic Diseases Endometrial Neoplasms Uterine Cervical Diseases Vulvar Neoplasms Uterine Neoplasms Endometrial cancer Vulvar Diseases Vulvar cancer Additional relevant MeSH terms: Female Urogenital Diseases and Pregnancy Complications Neoplasms Hemic and Lymphatic Diseases Neoplasms by Site Female Urogenital Diseases Lymphedema ClinicalTrials.gov processed this record on February 29, 2008 -------------------------------------------------------------------------------------- Treatment of Lymphedema: Application of the Kinesio Taping This study is currently recruiting participants. Verified by National Taiwan University Hospital, August 2004 Sponsored by: National Taiwan University Hospital Information provided by: National Taiwan University Hospital ClinicalTrials.gov Identifier: NCT00155220 Purpose There are 2 parts to this study. First part: Reliability of water displacement, circumference, tonometer. Effect of taping: lifting effect measured with sonography Effect of taping: peripheral circulation measured with DRT4 Second part: Effects of different intervention models including decongestive lymphatic therapy (DLT) and modified DLT Condition Intervention Phase Lymphedema Device: Low Stretch Bandage and Kinesio Tape Phase II Genetics Home Reference related topics: Lymphatic Diseases MedlinePlus related topics: Lymphatic Diseases U.S. FDA Resources Study Type: Interventional Study Design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment Official Title: Treatment of Lymphedema- Application of the Kinesio Taping Further study details as provided by National Taiwan University Hospital: Primary Outcome Measures: The severity of swelling, such as arm circumference, volume of water displacement The evaluation will be executed 4 weeks before the interventions, before the intervention, after 4 week intervention and 3 months after intervention. Secondary Outcome Measures: Related symptoms, the upper extremity function and quality of life The evaluation time the same as primary outcomes Estimated Enrollment: 60 Study Start Date: August 2004 Estimated Study Completion Date: March 2006 Detailed Description: First part: To investigate the reliability study of water displacement and circumference measurement and the change in thickness of subcutaneous space measured by sonography and blood flow measured by DRT4 in normal subjects after applying K-tape. Second part: The incidence of breast carcinoma is in the second place in women in Taiwan. Lymphedema is a common complication after treatment of breast carcinoma; it will lead not only to cosmetic problems but is also uncomfortable, and causes functional limitation for patients. The common management for lymphedema is decongestive lymphatic therapy (DLT) including skin care, manual lymph drainage, remedial exercises and compression therapies. At present, all possible compression therapies for lymphedema have limitations. Patients have poor compliance in using short-stretch bandage and compression garments due to the climate in Taiwan. Applying kinesio tape (K-tape) became a new treatment method in physical therapy; the inventor Dr. Kase claimed that the K-tape can improve circulation and remove congestion. Besides, it demonstrated good therapeutic effects in clinical application. However, there are few studies to show the clinical effects of K-tape. This restricts the further application of K-tape. Following the previous study, the purpose is to compare the effects among traditional DLT, modified DLT which replaces bandage with K-tape, and DLT combined K-tape in patients with lymphedema. A randomized control study will be executed. Sixty patients with post-mastectomy lymphedema will be randomly grouped into taping, bandage and mixed groups. Each subject will go through 4 weeks of a control period, 4 weeks of an intervention period, and followed by 3 months of an observation period. The evaluation items include physical therapy assessment, the severity of swelling, such as arm circumference, volume of water displacement, related symptoms, the upper extremity function and quality of life. The evaluation will be executed 4 weeks before the interventions (start of control period), before the intervention (start of intervention period), after a 4 week intervention and 3 months after the intervention to compare the effects among 3 kinds of treatment. Subjects in each group will receive treatments including skin care, manual lymphatic drainage, pneumatic compression therapy and exercise during the intervention period; the taping group’s patients will receive additional K-tape treatment; the mixed group’s patients will receive K-tape combined bandage treatment. Each group will be treated 2 hours/time, 5 times/week; the entire course will take 4 weeks. Eligibility Ages Eligible for Study: 30 Years to 90 Years Genders Eligible for Study: Female Accepts Healthy Volunteers: No Criteria Inclusion Criteria: Female breast cancer lymphedema Unilateral lymphedema Lymphedema onset 3 months ago Moderate to severe lymphedema At least one measurement point greater than 2 cm Good compliance Exclusion Criteria: Port-a-cath on affected side of chest with adhesion Skin disease Restriction of active range of motion Affected upper extremity (UE) Other diseases or medication might lead to swelling Irremovable bracelet or ring Contacts and Locations Please refer to this study by its ClinicalTrials.gov identifier: NCT00155220 Locations Taiwan School and Graduate Institute of Physical Therapy College of Medicine, National Taiwan University Recruiting Taipei, Taiwan Contact: Jau-Yih Tsauo, PhD 88623123456 ext 7320 jytsauo@ntu.edu.tw Principal Investigator: Jau-Yih Tsauo, PhD Sponsors and Collaborators National Taiwan University Hospital Investigators Study Chair: Jau-Yih Tsauo, PhD NTUH More Information Study ID Numbers: 9261701436 First Received: September 8, 2005 Last Updated: January 25, 2006 ClinicalTrials.gov Identifier: NCT00155220 Health Authority: Taiwan: Department of Health Study placed in the following topic categories: Lymphedema Lymphatic Diseases Additional relevant MeSH terms: Hemic and Lymphatic Diseases Lymphedema ClinicalTrials.gov processed this record on February 29, 2008 ------------------------------------------------------------------------------------ Breast Cancer Lymphedema: Role of Insulin Resistance/FOXC2 This study is currently recruiting participants. Verified by Stanford University, November 2007 Sponsors and Collaborators: Stanford University BCRP Information provided by: Stanford University ClinicalTrials.gov Identifier: NCT00383604 Purpose To better understand the mechanisms leading to lymphedema development in breast cancer survivors, and the implications for potential innovative approaches to the screening, prevention and treatment of this condition. Condition Breast Cancer Lymphedema Genetics Home Reference related topics: Lymphatic Diseases breast cancer MedlinePlus related topics: Breast Cancer Lymphatic Diseases ChemIDplus related topics: Insulin U.S. FDA Resources Study Type: Observational Study Design: Retrospective Official Title: Breast Cancer Lymphedema: Role of Insulin Resistance/FOXC2 Further study details as provided by Stanford University: Estimated Enrollment: 30 Study Start Date: July 2005 Detailed Description: Lymphedema of the arm is an important, under-recognized, and under-treated complication of successful surgical and radiotherapeutic treatment of breast cancer. As a result of advances in early detection and effective adjuvant therapies, many women diagnosed with breast cancer today can expect survival that is similar to age-matched women without breast cancer. Nevertheless, this source of substantial physical and psychological morbidity has not attracted sufficient attention from industry or the scientific research community to result in either effective risk stratification or the availability highly effective therapeutic interventions. While the presence and degree of arm edema can, in part, correlated with the extent of axillary surgery, we still comprehend only poorly the factors that predispose to overt lymphatic insufficiency in the patients at risk for lymphedema by virtue of prior breast cancer treatment. It is likely that this anatomic and regenerative variability relies, at least in part, upon an as yet undefined genetic substrate. A growing body of evidence suggests that mutations in the nuclear transcription gene FOXC2 are responsible for a broad clinical array of primary lymphedema syndromes. The biology of breast cancer-associated lymphedema, including its characteristic latency phase, suggests that similar mechanisms may operate in the predisposition to this and other forms of secondary lymphedema. In parallel, breast cancer-associated lymphedema has several clinical attributes that suggest a relationship to, and a role for, insulin resistance. In this regard, it is interesting to contemplate the recent, multiple lines of evidence that suggest that the gene FOXC2 regulates, directly or indirectly, several aspects of adipocyte metabolism and that genetic variability in the gene may influence features associated with the insulin resistance and the metabolic syndrome. These observations are of particular interest because of the recognized relationship of FOXC2 haploinsufficiency to a variety of identified lymphedema syndromes. It is therefore attractive to conjecture that insulin resistance, perhaps mediated through polymorphisms of FOXC2,.confers secondary lymphedema risk and predisposes to the as yet poorly understood tendency for breast cancer survivors to acquire substantial, pathological deposits of adipose tissue in the affected extremities with chronicity of the lymphedema. The specific aims of this proposal are as follows: (1) to quantitatively assess insulin sensitivity in late breast cancer survivors, equally divided among subjects who display clinical evidence of ipsilateral arm edema and those that do not; (2) to correlate the presence of relative insulin resistance to the expression of breast cancer-associated lymphedema. It is hypothesized that such an approach has the capability to lead to future elaboration of appropriate risk stratification and targeted therapeutic interventions; (3) as a pilot investigation, to sequence the FOXC2 gene, including the untranslated 5' region, in each these patients, to identify potential polymorphisms that might correlate both to the presence of insulin resistance and lymphedema risk. Eligibility Ages Eligible for Study: 18 Years and older Genders Eligible for Study: Female Accepts Healthy Volunteers: No Criteria Inclusion Criteria:- Patients enrolled in the proposed studies must be survivors of breast cancer at a time point at least 4 years following the initial surgery and radiotherapy for the disease. Patients must have a history of unilateral axillary lymph node dissection. Patients referred to, or that receive their care within the Stanford University Breast Cancer Program and the Stanford Center for Lymphatic and Venous Disorders. Patients will be required to have the capacity to provide informed consent. Exclusion Criteria:- Patients with other serious systemic illness (renal failure, hepatic dysfunction, congestive heart failure, neurological or psychological impairment) that would confound the study or impair the patients' ability to participate. Patients will not be enrolled if they are taking drugs that affect carbohydrate metabolism. Patients with recurrent breast cancer or other forms of pre-existing lymphedema will be ineligible. Contacts and Locations Please refer to this study by its ClinicalTrials.gov identifier: NCT00383604 Locations United States, California Stanford University School of Medicine Recruiting Stanford, California, United States, 94305 Contact: Ivana Drazin-Ivelja 650-498-4460 RocksonResearch@cvmed.stanford.edu Contact: Cancer Clinical Trials Office (650) 498-7061 Principal Investigator: Stanley G Rockson Sponsors and Collaborators Stanford University BCRP Investigators Principal Investigator: Stanley G Rockson Stanford University More Information Study ID Numbers: BRSNSTU0009, BRSNSTU0009, NCT00383604 First Received: September 29, 2006 Last Updated: December 4, 2007 ClinicalTrials.gov Identifier: NCT00383604 Health Authority: United States: Institutional Review Board Study placed in the following topic categories: Lymphedema Lymphatic Diseases Hyperinsulinism Metabolic Diseases Skin Diseases Connective Tissue Diseases Breast Neoplasms Insulin Resistance Metabolic disorder Glucose Metabolism Disorders Insulin Breast Diseases Additional relevant MeSH terms: Skin and Connective Tissue Diseases Neoplasms Hemic and Lymphatic Diseases Neoplasms by Site Lymphedema Nutritional and Metabolic Diseases ClinicalTrials.gov processed this record on February 29, 2008 ----------------------------------------------------------------------------------- Lymphedema Prophylaxis in Breast Cancer Survivors Who Show Early Evidence of High-Risk Status This study is currently recruiting participants. Verified by Stanford University, November 2007 Sponsored by: Stanford University Information provided by: Stanford University ClinicalTrials.gov Identifier: NCT00383500 Purpose To compare the effectiveness of usual treatments for lymphedema (massage and elastic sleeve), instituted even before the development of swelling, compared to the use of a newly marketed device, the Flexitouch®, which electronically simulates the effect of massage upon lymph flow. Condition Intervention Breast Cancer Lymphedema Device: Flexitouch Genetics Home Reference related topics: Lymphatic Diseases breast cancer MedlinePlus related topics: Breast Cancer Lymphatic Diseases U.S. FDA Resources Study Type: Interventional Study Design: Prevention, Randomized, Single Blind, Active Control, Parallel Assignment Official Title: To Prospectively Evaluate the Potential for Simple, Effective Lymphedema Prophylaxis in Breast Cancer Survivors Who Show Early Evidence of High-Risk Status Further study details as provided by Stanford University: Primary Outcome Measures: To prospectively assess the presence of newly developing lymphedema in each study subgroup through serial assessment of segmental interstitial fluid content by multiple frequency bioimpedance Secondary Outcome Measures: To evaluate the preventive interventions in a prospective, randomized fashion, contrasting the responses of equivalent numbers of patients randomized to 2 experimental arms and the control arm of the study To correlate the bioimpedance findings with concurrently derived, serial assessments of limb volume Estimated Enrollment: 200 Study Start Date: May 2005 Detailed Description: The current investigation is designed to prospectively evaluate the potential for simple, effective lymphedema prophylaxis in breast cancer survivors who show early evidence of high-risk status. There is growing evidence that the mechanisms of lymphatic repair after injury are mediated through lymphatic flow. Accordingly, we propose that physical measures designed to prophylactically augment lymphatic flow after surgical interventions for breast cancer will reduce the incidence and degree of lymphatic stagnation when compared to patients who receive conventional 'watch and wait' interventions. The specific aims of the study are to prospectively assess the presence of newly developing lymphedema in each study subgroup through serial assessment of segmental interstitial fluid content by multiple frequency bioimpedance to evaluate the preventive interventions in a prospective, randomized fashion, contrasting the responses of equivalent numbers of patients randomized to 2 experimental arms and the control arm of the study to correlate the bioimpedance findings with concurrently derived, serial assessments of limb volume Recent advances in our comprehension of the biological processes of lymphatic development and repair suggest that these mechanisms may be able to be manipulated to enhance the regenerative responses in the lymphatic vasculature following injury. Breast cancer-associated lymphedema is a prototype of such an acquired form of lymphatic vasculature insufficiency. Clinically, this poses a substantial clinical problem. It is estimated at one woman in four who survives a breast cancer intervention will develop lymphedema, often progressively. The appearance of lymphedema has documented adverse effects on physical and psychologically well-being. Our new insights into lymphatic repair suggest that such mechanisms can be employed in a prophylactic fashion to forestall or eliminate the development of lymphedema. This proposal is designed to investigate this hypothesis in a prospective fashion, using a randomized trial design in 80 patients enrolled at the time of breast cancer surgery. If the investigation documents a beneficial effect of preventive measures, it could have a profound impact on subsequent breast cancer care. These measures are simple and cost-effective and, could help to eliminate the impact of a substantial detractor to the improved longevity and health that breast cancer survivors otherwise may expect to enjoy. Eligibility Ages Eligible for Study: 18 Years and older Genders Eligible for Study: Female Accepts Healthy Volunteers: No Criteria Inclusion Criteria:1. Patients referred to the surgeons of the Stanford University Breast Cancer Program 2. Patients will be required to have the capacity to provide informed consent. 3. All experimental protocols will be reviewed and approved by the Stanford Institutional Review Board for the Protection of Human Subjects. 4. All of the subjects to be enrolled in the proposed studies will be patients with unilateral breast cancer who are scheduled to undergo breast surgery and axillary lymph node dissection, with or without breast conserving techniques. Exclusion Criteria:1. Patients with other serious systemic illness (renal failure, hepatic dysfunction, congestive heart failure, neurological or psychological impairment) that would confound the study or impair the patients' ability to participate. 2. Patients with recurrent breast cancer or other forms of pre-existing lymphedema will be ineligible. Contacts and Locations Please refer to this study by its ClinicalTrials.gov identifier: NCT00383500 Locations United States, California Stanford University School of Medicine Recruiting Stanford, California, United States, 94305 Contact: Ivana Drazin-Ivelja 650-498-4460 RocksonResearch@cvmed.stanford.edu Contact: Cancer Clinical Trials Office (650) 498-7061 Principal Investigator: Stanley G Rockson Sponsors and Collaborators Stanford University Investigators Principal Investigator: Stanley G Rockson Stanford University More Information Study ID Numbers: BRSNSTU0007, BRSNSTU0007, NCT00383500 First Received: September 29, 2006 Last Updated: December 4, 2007 ClinicalTrials.gov Identifier: NCT00383500 Health Authority: United States: Institutional Review Board Study placed in the following topic categories: Lymphedema Lymphatic Diseases Skin Diseases Connective Tissue Diseases Breast Neoplasms Breast Diseases Additional relevant MeSH terms: Skin and Connective Tissue Diseases Neoplasms Hemic and Lymphatic Diseases Neoplasms by Site Lymphedema ClinicalTrials.gov processed this record on February 29, 2008 -------------------------------------------------------------------------------- The Use of Selenium to Treat Secondary Lymphedema - Breast Cancer This study is currently recruiting participants. Verified by University Health Network, Toronto, September 2005 Sponsors and Collaborators: University Health Network, Toronto Princess Margaret Hospital, Canada Information provided by: University Health Network, Toronto ClinicalTrials.gov Identifier: NCT00188604 Purpose The primary objective of this study to assess the effectiveness of selenium compared to placebo in reducing the lymphedema in-patients with breast cancer. Secondary objectives are to assess the impact of selenium on patient’s quality of life and to assess the incidence of adverse effects of selenium therapy. Condition Intervention Phase Breast Neoplasms Lymphedema Drug: sodium selenite Phase II Genetics Home Reference related topics: Lymphatic Diseases breast cancer MedlinePlus related topics: Breast Cancer Lymphatic Diseases ChemIDplus related topics: Selenium Sodium selenite U.S. FDA Resources Study Type: Interventional Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study Official Title: A Randomized Phase II Placebo-Controlled Double Blind Study of Using Selenium in the Treatment of Secondary Lymphedema in Breast Cancer Patients Further study details as provided by University Health Network, Toronto: Primary Outcome Measures: To assess the effectiveness of orally administered selenium compared to placebo in reducing arm lymphedema in patients treated with surgery (axiallary nodal dissection) and radiotherapy for breast cancer. Secondary Outcome Measures: To assess the toxicity of selenium. To assess the association of selenium, quality of life and limb function. Estimated Enrollment: 34 Study Start Date: January 2004 Eligibility Ages Eligible for Study: 18 Years and older Genders Eligible for Study: Female Accepts Healthy Volunteers: No Criteria Inclusion Criteria: patients with clinically documented lymphedema of upper limb secondary to breast cancer management (surgery - axillary nodal dissection, and radiotherapy) patients who have had other modalities of management can be included, e.g. physical therapy, pharmacological therapy ECOG performance 0-2 informed consent Exclusion Criteria: active cellulitis/skin infection of the limb venous thrombosis of the upper limbs active malignancy any other medical condition or congenital or traumatic injury involving either limb patients already on selenium medication patients participating in another clinical study related to lymphedema Contacts and Locations Please refer to this study by its ClinicalTrials.gov identifier: NCT00188604 Contacts Contact: Wilfred Levin, MD 416-946-2127 wilfred.levin@rmp.uhn.on.ca Locations Canada, Ontario Princess Margaret Hospital Recruiting Toronto, Ontario, Canada, M5G 2M9 Contact: Wilfred Levin, MD 416-946-2127 wilfred.levin@rmp.uhn.on.ca Sponsors and Collaborators University Health Network, Toronto Princess Margaret Hospital, Canada Investigators Principal Investigator: Wilfred Levin, MD Princess Margaret Hospital, Canada More Information Study ID Numbers: UHN REB 03-0741-C First Received: September 12, 2005 Last Updated: September 12, 2005 ClinicalTrials.gov Identifier: NCT00188604 Health Authority: Canada: Ethics Review Committee Study placed in the following topic categories: Lymphedema Selenium Lymphatic Diseases Skin Diseases Connective Tissue Diseases Neoplasm Metastasis Breast Neoplasms Breast Diseases Additional relevant MeSH terms: Skin and Connective Tissue Diseases Neoplasms Hemic and Lymphatic Diseases Neoplasms by Site Lymphedema ClinicalTrials.gov processed this record on February 29, 2008 ---------------------------------------------------------------------------------- Massage Therapy for Breast Cancer Treatment-Related Swelling of the Arms This study is currently recruiting participants. Verified by National Center for Complementary and Alternative Medicine (NCCAM), January 2007 Sponsored by: National Center for Complementary and Alternative Medicine (NCCAM) Information provided by: National Center for Complementary and Alternative Medicine (NCCAM) ClinicalTrials.gov Identifier: NCT00058851 Purpose The purpose of this study is to examine the short-term and long-term efficacy of massage therapy alone compared to massage therapy plus compression bandaging in the treatment of breast cancer treatment-related swelling of the arms and legs. Condition Intervention Phase Lymphedema Procedure: Manual lymph drainage Procedure: Combined physiotherapy Procedure: Compression bandaging Phase II Genetics Home Reference related topics: Lymphatic Diseases MedlinePlus related topics: Lymphatic Diseases U.S. FDA Resources Study Type: Interventional Study Design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study Official Title: Massage Therapy for Breast Cancer-Related Lymphedema Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM): Primary Outcome Measures: volume change Estimated Enrollment: 88 Study Start Date: January 2003 Estimated Study Completion Date: May 2007 Detailed Description: Massage therapy (in the form of manual lymph drainage [MLD]) and compression bandaging (CB) are integral components of combined physical therapy (CPT), the recommended treatment for peripheral lymphedema (LE). According to the World Health Organization, LE afflicts hundreds of millions worldwide and probably millions in the United States. Effects of various forms of massage on lymph circulation have been postulated for more than a century, but the efficacy of MLD alone without CB has not been demonstrated. New data suggest that MLD alone reduces established LE volume as effectively as CB in combination with CPT and minimizes LE development. Patients will be randomly assigned to either treatment with MLD alone or a combination of MLD and CB. Patients will be treated in 10 one-hour sessions over 2 weeks. They will also undergo lymphangioscintigraphy (a nuclear medicine test) to depict the function of their lymphatic system. Patients will continue self treatment at home and will be followed for 6 months. Eligibility Genders Eligible for Study: Both Accepts Healthy Volunteers: No Criteria Inclusion Criteria: Lymphedema (5% to 20% increase in volume) after breast cancer treatment Exclusion Criteria: Physically unable to perform massage or bandaging during home program Contacts and Locations Please refer to this study by its ClinicalTrials.gov identifier: NCT00058851 Locations United States, Arizona University of Arizona Recruiting Tucson, Arizona, United States, 85724 Contact: Michael J. Bernas, MS 520-626-6118 michaelb@u.arizona.edu Contact: Marlys H. Witte, MD 520-626-6118 lymph@u.arizona.edu Sponsors and Collaborators National Center for Complementary and Alternative Medicine (NCCAM) Investigators Principal Investigator: Marlys Witte, MD University of Arizona More Information Study ID Numbers: |