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
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.
Procedure: management of therapy complications
Procedure: quality-of-life assessment
|Study Design:||Allocation: Randomized
Masking: Single Blind
Primary Purpose: Supportive Care
|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|
- Lower-extremity volumes for both unaffected and affected legs [ Designated as safety issue: No ]
- Quality of life (QOL) and functional status [ Designated as safety issue: No ]
- Pain in affected limb [ Designated as safety issue: Yes ]
- Deep-vein thrombosis [ Designated as safety issue: Yes ]
- Cellulitis [ Designated as safety issue: Yes ]
- Need for unscheduled visits at the patients' lymphedema clinic [ Designated as safety issue: Yes ]
|Study Start Date:||December 2007|
|Estimated Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
- 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 treatment.
|United States, Connecticut|
|George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus|
|New Britain, Connecticut, United States, 06050|
|United States, Illinois|
|Robert H. Lurie Comprehensive Cancer Center at Northwestern University|
|Chicago, Illinois, United States, 60611-3013|
|United States, Ohio|
|Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center|
|Columbus, Ohio, United States, 43210-1240|
|United States, Oklahoma|
|Oklahoma University Cancer Institute|
|Oklahoma City, Oklahoma, United States, 73104|
|Cancer Care Associates - Saint Francis Campus|
|Tulsa, Oklahoma, United States, 74136-1929|
|United States, Rhode Island|
|Women and Infants Hospital of Rhode Island|
|Providence, Rhode Island, United States, 02905|
|United States, South Carolina|
|Hollings Cancer Center at Medical University of South Carolina|
|Charleston, South Carolina, United States, 29425|
|United States, Virginia|
|Carilion Gynecologic Oncology Associates|
|Roanoke, Virginia, United States, 24014|
|United States, Wisconsin|
|Aurora Women's Pavilion of West Allis Memorial Hospital|
|West Allis, Wisconsin, United States, 53227|
|Study Chair:||Levi S. Downs, MD||Masonic Cancer Center, University of Minnesota|