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
18 Years
N/A
Female
Cervical Cancer, Endometrial Cancer, Lymphedema, Vulvar Cancer
Trial Information
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
OBJECTIVES:
Primary
- 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.
Secondary
- 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.
Tertiary
- 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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of unilateral lower-extremity lymphedema as a result of surgery,
chemotherapy, and/or radiation therapy for cervical, vulvar, or endometrial cancer
- Prior to acute clinic therapy, the affected limb edema must have been greater than
stage I and must have had at least a 10% excess volume over the unaffected limb
- No clinic therapy for lower-extremity lymphedema for 6 months prior to the start of
the patient's acute clinic therapy
- Must be within 3 years from the completion of therapy for original gynecologic cancer
diagnosis
- At the time of completion of acute clinic therapy, patients must have reached their
nadir limb volume for two consecutive measurements each 7-10 days apart
- No known active or recurrent cancer
PATIENT CHARACTERISTICS:
- GOG performance status 0-2
- Not pregnant
- No history of peripheral vascular disease (venous or arterial), pulmonary edema,
congestive heart failure, or chronic renal disease
- No current diagnosis of deep-vein thrombosis or phlebitis in the affected limb
- No open wound(s) or active infection of the affected limb
- No history of chronic lower-extremity lymphoma that predates cancer diagnosis
- No poorly controlled asthma
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- More than 3 months since prior cancer treatment
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Single Blind, Primary Purpose: Supportive Care
Outcome Measure:
Lower-extremity volumes for both unaffected and affected legs
Safety Issue:
No
Principal Investigator
Levi S. Downs, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Masonic Cancer Center, University of Minnesota
Authority:
Unspecified
Study ID:
CDR0000579834
NCT ID:
NCT00577317
Start Date:
December 2007
Completion Date:
Related Keywords:
- Cervical Cancer
- Endometrial Cancer
- Lymphedema
- Vulvar Cancer
- lymphedema
- stage 0 cervical cancer
- stage IA cervical cancer
- stage IB cervical cancer
- stage IIA cervical cancer
- stage IIB cervical cancer
- stage III cervical cancer
- stage IVA cervical cancer
- stage IVB cervical cancer
- stage 0 endometrial carcinoma
- stage I endometrial carcinoma
- stage II endometrial carcinoma
- stage III endometrial carcinoma
- stage IV endometrial carcinoma
- stage 0 vulvar cancer
- stage I vulvar cancer
- stage II vulvar cancer
- stage III vulvar cancer
- stage IV vulvar cancer
- Endometrial Neoplasms
- Sarcoma, Endometrial Stromal
- Uterine Cervical Neoplasms
- Lymphedema
- Vulvar Neoplasms
- Adenoma
Name | Location |
|---|---|
| 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 |
