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

Gynecologic Oncology Group (GOG)

Status and phase: Terminated; Phase 3

Conditions: Stage IVA Cervical Cancer; Stage 0 Vulvar Cancer; Stage IB Cervical Cancer; Stage II Uterine Corpus Cancer; Stage IVB Vulvar Cancer; Stage IVB Cervical Cancer; Stage III Uterine Corpus Cancer; Stage 0 Cervical Cancer; Stage III Vulvar Cancer; Stage I Uterine Corpus Cancer; Stage III Cervical Cancer; Stage IV Uterine Corpus Cancer; Stage IIB Cervical Cancer; Stage IIA Cervical Cancer; Lymphedema; Stage IA Cervical Cancer; Stage 0 Uterine Corpus Cancer; Stage II Vulvar Cancer; Stage I Vulvar Cancer

Treatments: Other: Quality-of-Life Assessment; Procedure: Management of Therapy Complications

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT00577317

NCI-2009-00602 (Registry Identifier)

CDR0000579834

U10CA101165 (U.S. NIH Grant/Contract)

GOG-0236 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2 participants in 2 patient groups

Arm 1

Experimental group

Description:

Patients receive standard home maintenance therapy and perform self-manual lymphatic drainage once daily for 60 minutes for 24 weeks.

Treatment:

Procedure: Management of Therapy Complications

Other: Quality-of-Life Assessment

Procedure: Management of Therapy Complications

Arm II

Experimental group

Description:

Patients receive Flexitouch® home maintenance therapy once daily for 60 minutes for 24 weeks

Treatment:

Procedure: Management of Therapy Complications

Other: Quality-of-Life Assessment

Procedure: Management of Therapy Complications