Clinical Trials for Lymphedema

There are several clinical trials available for lymphedema. This is great news, since lymphedema is never one of the hot research topics! If you are eligible for any of these trials and live in the surrounding areas, I urge you to get more information about these trials and participate if you can.

While clinical trials may not help your personal situation, think how good you would feel to know that you have pioneered new avenues of treatment for other patients.

I participated in two clinical trials to date - Sentinel Node Biopsy versus Axillary Node Dissection and now SNB is the standard of care in many hospitals, allowing women to avoid complete axillary dissection and lessening (but not eradicating!) their risk of lymphedema.

Another clinical trial I joined was virtual colonoscopy versus standard colonoscopy. One day, virtual colonoscopy may be offered as the initial screening test, thus avoiding possible tears in the colon and allowing the patient to complete the study, without any anesthesia, in about 15 minutes.

Here are the trials available (or soon to be recruiting):

Biolectric measurement of water volume versus water displacement. Includes dose of Pycnogenol (French pine tree bark) as treatment for LE.

Excluded: Patients undergoing chemotherapy or radiation; patients with cellulitis or venous clots or woody fibrosis.

Study began: August 2003

University of Wisconsin Dr. Paul Hutson 608-263-2496

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Comparison of MLD (manual lymphatic drainage) and CB (compression bandaging) versus MLD alone

Excluded: Patients physically unable to perform self-massage and/or bandaging at home.

Study began: January 2003

University of Arizona Marlys Witte, MD 520-626-6118

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Axillary Drainage following Lymph Node Dissection

Comparison of three randomized groups: High vacuum drainage, low vacuum drainage, simple tube drainage

Excluded: No prior mastectomy, no immediate reconstruction, not pregnant, no stage III or above breast cancer.

Study begins: Currently in recruitment

Royal Marsden Hospital, England Anthony G. Nash, MD 44-20-8642-6011

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Fibrin sealant after groin lymph node removal

Fibrin sealant may decrease lymphedema after lymph node removal. Randoimzed trial: group 1 receives fibring sealant to surgical site; group 2 receive standard of care.

Included: Vulvar malignancy, stages 1-IVb, planned vulvectomy or hemivulvectomy and inguinal lymphadenectomy.

Excluded: No primary or secondary lymphedema of lower extremities.

Study began: Currently recruiting.

National Cancer Institute: Gynecologic Oncology Group Locations available in Alabama, California, Colorado, Connecticut, District of Columbia, Florida, Hawaii, Illinois, Indiana, Iowa, Kentucky, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, New Jersey, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Vermont, Washington, Wisconsin, Australia, Canada, Norway and England.

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