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
NCT00577317 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2
Last updated 2021-06-23
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.
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
Interventions
- PROCEDURE
-
Management of Therapy Complications
Receive standard home maintenance therapy and perform self-manual lymphatic drainage
- PROCEDURE
-
Management of Therapy Complications
Receive Flexitouch home maintenance therapy
- OTHER
-
Quality-of-Life Assessment
Ancillary studies
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
Gynecologic Oncology Group
lead NETWORK
Principal Investigators
-
Levi Downs · Gynecologic Oncology Group
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-12-31
- Primary Completion
- 2009-07-27
- Completion
- 2009-07-27
Countries
- United States
Study Locations
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