Clinical trial NCT00577317: 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
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Lymphedema
Stage 0 Cervical Cancer
Stage 0 Uterine Corpus Cancer
Stage 0 Vulvar Cancer
Stage I Uterine Corpus Cancer
Stage I Vulvar Cancer
Stage IA Cervical Cancer
Stage IB Cervical Cancer
Stage II Uterine Corpus Cancer
Stage II Vulvar Cancer
Stage IIA Cervical Cancer
Stage IIB Cervical Cancer
Stage III Cervical Cancer
Stage III Uterine Corpus Cancer
Stage III Vulvar Cancer
Stage IV Uterine Corpus Cancer
Stage IVA Cervical Cancer
Stage IVB Cervical Cancer
Stage IVB Vulvar Cancer
Lead sponsor: GOG Foundation
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-12-20
Enrollment: 2
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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. 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.

Detailed description: PRIMARY OBJECTIVE:

I. 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 OBJECTIVE:

I. 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

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.

Eligibility criteria: Criteria:

* Has lower-extremity lymphedema on one side of the body caused by surgery, chemotherapy, and/or radiation therapy.
* At least 6 months since clinic therapy for lower-extremity lymphedema
* Is within 3 years from finishing cancer treatment
* No active or recurrent cancer
* More than 3 months since cancer treatment

Primary outcomes:
measure: Lower-extremity Volumes for Both Unaffected and Affected Legs
timeFrame: From registration to study discontinuation. A maximum of 7 months.
Secondary outcomes:
measure: Quality of Life (QOL) and Functional Status as Assessed by the Lymphedema Questionnaire
timeFrame: From registration to study discontinuation. A maximum of 7 months.
measure: Compliance With Treatment as Assessed by the Number of Days Per Week Using MLD or Flexitouch System and Duration/Day of MLD and Flexitouch System Treatment
timeFrame: From registration to study discontinuation. A maximum of 7 months.
measure: Pain in Affected Limb
timeFrame: From registration to study discontinuation. A maximum of 7 months.
measure: Incidence of Deep-vein Thrombosis
timeFrame: From registration to study discontinuation. A maximum of 7 months.
measure: Incidence of Cellulitis
timeFrame: From registration to study discontinuation. A maximum of 7 months.
measure: Need for Unscheduled Visits at the Patients' Lymphedema Clinic
timeFrame: From registration to study discontinuation. A maximum of 7 months.
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Gynecologic Oncology Group
state: Pennsylvania
Study officials:
affiliation: Gynecologic Oncology Group
name: Levi Downs
role: PRINCIPAL_INVESTIGATOR
References: