Clinical Trials and Studies
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The International Lymphatic Disease and Lymphedema Patient Registry & Biorepository
We invite you to participate in this highly significant development for the patient community. An international patient registry paves the way for future clinical trials of experimental drugs and therapies designed to treat lymphatic diseases. We encourage all patients to participate in this important initiative.
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Biomarker and Phenotypic Risk Factors for Breast Cancer LymphedemaThe University of California San Francisco is conducting a study to investigate these symptoms related to lymphedema. Mount Sinai is a New York City study site where you can enroll in the study locally. Participants who compete the study will receive $150 for their time.
If you are a woman 18 years of age or older and have completed your active treatment (surgery, chemotherapy or radiation) for breast cancer at least six months ago, you may be eligible. We are currently enrolling women with lymphedema.
Study Involves:
- Completion of questionnaires
- One 2-hour visit to The Mount Sinai Hospital that involves:
- Movement & Sensation Evaluation
- Arm & Body Measurements
- Blood Sample CollectionFor more information, contact us by phone at 212-241-8055 or email at Nursing.Research@mountsinai.org.
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Stanford Study On Response To Drug Therapy For Lymphedema
Researchers at Stanford University in Stanford, CA are conducting a study on the response to drug therapy for lymphedema. You may be eligible for this study if you have chronic lymphedema and are eligible for the drug therapy. Participants will not be paid for their participation. The study length is approximately 6 months.
All prospective study subjects who are not current patients of the lymphedema treatment clinic at the Stanford Center for Lymphatic and Venous Disorders must first be evaluated by Dr. Rockson to assess if they are appropriate candidates for the study. There are two study appointments after the initial clinical evaluation. If interested, or for more information, please contact:
Leslie Roche RN, Clinical Research Coordinator Email address: lesroche@stanford.edu
For general information about participant rights, contact 1-866-680-2906.
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Recovery & Rejuvenation ProjectThis is a partnership between the Recovery & Rejuvenation project at Arizona State University, the Mayo Clinic, the University of Arizona, and community organizations in the Phoenix metropolitan area. The purpose of this project is to explore ways of helping women recover from breast cancer. It is very common for breast cancer survivors to report low energy, lack of focus, poor memory or trouble sleeping for months and even years after treatment. The goal of this project is to explore ways to improve energy levels through classes designed to help participants find their way back to wellness.
The project focus is on women who:
o Have been diagnosed with Stage 0 to III breast cancer
o Are 6 months to 10 years past primary treatment
o Age: 45-75Eligibility process:
o 1st step: 10-15 minute pre-screen that goes over health history and diagnosis.
o 2nd step: if eligible after the pre-screen, a 10-15 minute in-person meeting will be scheduled to complete the process and an informed consent will be obtained.Classes:
o Women will be randomly assigned to one of three classes. Two of the classes will focus on gentle movement. The third class will have a book club format and will focus on readings that are designed to educate and support women through their recovery.
o Classes will be scheduled for one hour each week, for a total of 8 consecutive weeks. All class materials will be provided at the first class. The classes will take place at various community site locations throughout the Phoenix Metropolitan area.
o Participants will take part in three health assessments: before and after the eight class sessions, and 24 weeks after classes end. Blood and saliva samples will be collected as well as questionnaires related to diet, sleep and activity level.Benefits:
o Participating women may improve levels of vitality, physical activity, sleep quality, mood, cognitive function, peripheral neuropathy, and inflammation.This research project is supported by the National Cancer Institute of the National Institutes of Health under Award Number R01CA182901.
If you have any questions you can contact us by phone at (602) 496-2329 or by email at recovery.rejuvenation@asu.edu.
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BIDMC Acupuncture for Breast Cancer Related Lymphedema StudyResearchers at Beth Israel Deaconess Medical Center in Boston, MA are conducting a study to demonstrate the feasibility and effectiveness of acupuncture for patients with breast cancer related lymphedema.
You may be eligible for this study if you have a single arm affected by lymphedema following breast cancer treatment.
Participants will be paid $50 for their time and will receive acupuncture treatments free of charge.The study length is 6 weeks.
All prospective study subjects who are not current patients of the lymphedema treatment clinic at BIDMC must first be evaluated by Dr. Singhal to assess if they are appropriate candidates for the study (a comprehensive lymphedema evaluation) and then have clinical measurements taken by a certified lymphedema therapist. (These two appointments are outside of the study).
There are a total of 12 acupuncture sessions which take place over a 6-week period. Acupuncture sessions generally begin 1-2 weeks after a patient has had their baseline evaluation (lab work and clinical measurements). Clinical measurements are repeated at week 3 (midpoint) of the study. At the end of the study (week 6), participants have clinical measurements and bloodwork taken.
There are two study groups (all patients are offered 12 acupuncture sessions regardless of initial group assigned!)—one group receives 12 acupuncture sessions right away during this 6 week period (after baseline evaluation), and the other group is monitored clinically for 6-weeks, but then receives their 12 acupuncture treatments after that time period.
All parking-related costs are reimbursed by the study.Please contact the study team to find out more or to see if you are eligible:
Dhruv Singhal, MD
Email address: lymphaticsurgery@bidmc.harvard.edu
Phone Number: 617-632-7855 -
Vanderbilt Lymphedema/Lipedema MRI StudyVolunteers Needed for Lymphedema and Lipedema Research Study
We are ENROLLING women who
-have lymphedema in a leg following cancer treatment
-are comfortable in an MRI scannerThe purposes of this study are
-to investigate the potential of MRI serving as a diagnostic tool for lipedema
-to better understand the tissue composition of legs with secondary lymphedema
-to better comprehend how lymphedema and lipedema effect the lymphatic systemThe study is a one-time visit of 3 hours and involves an MRI scan of the body. Volunteers will be appropriately compensated for participating in the study. If you are interested in further information, please email INFORM@vumc.org or call 615-343-2011.
Study Site Location: Nashville, TN
Vanderbilt University Institute of Imaging Science
1161 21st Ave S AA-1105, Nashville, TN 37232This research study is funded in part by grant support from the Lymphatic Education & Research Network and the Lipedema Foundation.
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Breast Cancer Survivor Study
Vanderbilt University School of Nursing is looking for female breast cancer survivors over the age of 18. Participation in the study involves filling out surveys. Download a flyer here.
If interested, please contact Melissa at 615-343-6313 or lymphresearch@vanderbilt.edu.
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ULTRA: A Phase 2 Study of the Investigational Medication Ubenimex in Lymphedema
ULTRA is Ubenimex in adult patients with Lymphedema of The lower limb: a Phase 2, RAndomized, double-blind, placebo-controlled study of efficacy, safety, and pharmacokinetics.
This study is being expanded to include both patients with primary lymphedema not of congenital onset, as well as secondary lymphedema.
Eligible patients must have a diagnosis of leg lymphedema and must have completed a full course of complete decongestive therapy (CDT) at least 4 weeks prior to screening, including use of compression garments for at least 4 weeks without change in regimen. Patients must also be willing to maintain a stable regimen of self-care, including use of compression garments from screening through the entire study duration (through the safety follow-up visit).Approximately 40 patients will be enrolled in the ULTRA study and will be randomized in a 1:1 ratio to receive ubenimex three times a day or TID (20 patients) or placebo three times a day or TID (20 patients) for 24 weeks.
Inquiries to participate should be directed to:
• Stanford University, Leslie Roche, RN, BSN (lesroche@stanford.edu, 650-723-1396)
• University of Florida Health Cancer Center at Orlando Health, Jennifer Quintiliani, RN, CCRP (Jennifer.quintiliani@orlandohealth.com, 321-843-2026)
• The Ohio State University, Columbus, Filiz Muharrem (filiz.muharrem@osumc.edu, 614-366-5844)To see if you may qualify to participate in this study please visit www.eigerLE.com or call 1-877-899-2051. This study is being sponsored by Eiger BioPharmaceuticals (www.eigerbio.com). For a complete description of the study, please go to clinicaltrials.gov (NCT02700529).
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University of California San Francisco (UCSF) Breast Cancer Related Lymphedema StudyUCSF researcher Christine Miaskowski, RN, PhD and colleagues are conducting a research study to learn more about the signs and symptoms of lymphedema associated with breast cancer treatments. Lymphedema is the swelling in the arms, shoulders, hands and/or breast area as a result of breast cancer treatment. The team also wants to know if there are genetic, (i.e., inherited) factors that predict whether patients develop lymphedema or not.
To be eligible to participate in the Risk Factors of Breast Cancer Lymphedema Study, you must:• Be female, at least 18 years old
• Have had breast cancer on one side only
• Completed surgery for breast cancer & any other breast cancer treatment (radiation and chemotherapy) at least 6 months ago
• Have a diagnosis of breast cancer treatment-related lymphedemaParticipants will complete online questionnaires and have a one-time study visit to UCSF, Parnassus campus. Participants will be paid $150 for their time and travel.
To find out if you qualify or for other questions, contact the study research team at 855-855-UCSF (855-855-8273) toll free or email Judy Mastick, RN, study project director, at symptoms@ucsf.edu.
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Systemic Therapy to Treat Lymphatic Malformations
Clinical Trial at Stanford School of Medicine:
Dr. Joyce Teng, MD, PhD at Stanford University School of Medicine, CA is conducting a clinical trial on the use of Sildenafil treatment for patients ages 6 months - 10 years of age with Lymphatic Malformations (LM).
Participation involves visits to Stanford, as well as at local sub-sites being conducted in Chicago, IL, and Denver, Colorado. Duration is 20 - 52 weeks. There is no compensation for this study, but all travel is covered by Stanford. A separate study is also being conducted, which involves genetic testing of patients with lymphatic malformations.
To find out more information or to see if your child qualifies, please contact Elidia Tafoya, MPH, study coordinator, at 650-724-1982 or by email at etafoya@stanford.edu. To view clinical study flyer, click here.
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