Clinical Trials and Studies

BIDMC Acupuncture for Breast Cancer Related Lymphedema Study

Researchers 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.

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 Study

Volunteers 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 scanner

The 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 system

The 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@vanderbilt.edu or call 615-343-7182.

Study Site Location: Nashville, TN
Vanderbilt University Institute of Imaging Science
1161 21st Ave S AA-1105, Nashville, TN 37232

This research study is funded in part by grant support from the Lymphatic Education & Research Network and the Lipedema Foundation.
University of California San Francisco (UCSF) Breast Cancer Related Lymphedema Treatment Study

Researchers at UCSF are conducting a study to learn if treatment with a negative pressure massage device is safe and effective, compared to manual lymphatic drainage massage, at improving swelling, skin condition, and movement in the arms of women with lymphedema.

You may be able to take part in this study if you:

• Have had lymphedema in one arm for at least one year
• Your lymphedema has not changed significantly in the last 3 months

Participants will be paid $50 for their time, have parking reimbursed, and will receive 12 massage treatments for their lymphedema arm.

Please contact the study investigator to find out more or to see if you are eligible:

Betty Smoot, PT, DPTSc
707-494-8262
Betty.Smoot@ucsf.edu
PhysioTouch@ucsf.edu
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 Study

UCSF 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 lymphedema

Participants 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.
Head and Neck/Truncal Lymphedema Symptom Research Study

Vanderbilt University School of Nursing in Nashville, TN is conducting a study to test an online survey for people with some type of chronic swelling (lymphedema), including head and neck, back, chest, breast, abdomen/belly, groin, and genital swelling.

Participation is confidential and involves a one minute online screening survey and, if eligible, a one-time half-hour or less online survey.

You would not be paid to be in the study, but in just a few minutes you can help us to know more about the problems people with these types of chronic swelling (lymphedema) have.

If you are interested, please visit this link. If you prefer, you can contact Dr. Sheila H. Ridner and her research team at 615-343-4413 or by email at jennifer.k.doersam@vanderbilt.edu.

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Closed - Leg Lymphedema Symptom Research Study

Vanderbilt University School of Nursing in Nashville, TN is conducting a study to test an online survey for people with NO lymphedema and people with leg (lower limb) lymphedema.

Participation involves a quick online screening survey and, if eligible, a one-time twenty minute or less online survey.

There is no compensation for this study, but in just a few minutes you can help us better understand the problems people with this type of lymphedema experience.

If you are interested, please visit this link. If you prefer, you can contact Dr. Sheila H. Ridner and her research team at 615-343-4413 or by email at jennifer.k.doersam@vanderbilt.edu.

This study is now closed.
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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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Stanford Fibralign Biobridge Lymphedema Study

For women and men who have lymphedema of the arm, there is a growing interest in lymph node transfer as a surgical solution. Dr. Stanley G. Rockson and his research team at Stanford University are currently studying lymph node transfer for arm lymphedema, to determine the best possible approaches for a favorable outcome to the surgery. If you have arm lymphedema and are contemplating lymph node transfer surgery, you may be eligible to participate in this study. For more information, please call Eric Henderson at 650-723-1396 or e-mail ehenders@stanford.edu.

For general information about participant rights, contact: 1-866-680-2906.
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