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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

Phase 3
18 Years
Not Enrolling
Cervical Cancer, Endometrial Cancer, Lymphedema, Vulvar Cancer

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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



- 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

Inclusion Criteria


- 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

- 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


- 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


- See Disease Characteristics

- More than 3 months since prior cancer treatment

Type of Study:


Study Design:

Allocation: Randomized, Masking: Single Blind, Primary Purpose: Supportive Care

Outcome Measure:

Lower-extremity volumes for both unaffected and affected legs

Safety Issue:


Principal Investigator

Levi S. Downs, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Masonic Cancer Center, University of Minnesota



Study ID:




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



George Bray Cancer Center at the Hospital of Central Connecticut - New Britain CampusNew Britain, Connecticut  06050
Women and Infants Hospital of Rhode IslandProvidence, Rhode Island  02905
Carilion Gynecologic Oncology AssociatesRoanoke, Virginia  24014
Hollings Cancer Center at Medical University of South CarolinaCharleston, South Carolina  29425
Oklahoma University Cancer InstituteOklahoma City, Oklahoma  73104
Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical CenterColumbus, Ohio  43210-1240
Cancer Care Associates - Saint Francis CampusTulsa, Oklahoma  74136-1929
Aurora Women's Pavilion of West Allis Memorial HospitalWest Allis, Wisconsin  53227