Trials / Terminated
TerminatedNCT00577317
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
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
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 2 (actual)
- Sponsor
- Gynecologic Oncology Group · Network
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2007-12-01
- Primary completion
- 2009-07-27
- Completion
- 2009-07-27
- First posted
- 2007-12-20
- Last updated
- 2021-06-23
- Results posted
- 2021-06-23
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00577317. Inclusion in this directory is not an endorsement.