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
- 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.
- 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.
- 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.
Clinical staff measure patients' lower limb (both) volumes and patients complete quality of
life questionnaires at baseline, every 8 weeks during treatment, and at completion of study
Allocation: Randomized, Masking: Single Blind, Primary Purpose: Supportive Care
Lower-extremity volumes for both unaffected and affected legs
Levi S. Downs, MD
Masonic Cancer Center, University of Minnesota
|George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus||New Britain, Connecticut 06050|
|Women and Infants Hospital of Rhode Island||Providence, Rhode Island 02905|
|Carilion Gynecologic Oncology Associates||Roanoke, Virginia 24014|
|Hollings Cancer Center at Medical University of South Carolina||Charleston, South Carolina 29425|
|Oklahoma University Cancer Institute||Oklahoma City, Oklahoma 73104|
|Robert H. Lurie Comprehensive Cancer Center at Northwestern University||Chicago, Illinois 60611|
|Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center||Columbus, Ohio 43210-1240|
|Cancer Care Associates - Saint Francis Campus||Tulsa, Oklahoma 74136-1929|
|Aurora Women's Pavilion of West Allis Memorial Hospital||West Allis, Wisconsin 53227|