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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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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

Intervention / Treatment
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* Procedure: Management of Therapy Complications
* Procedure: Management of Therapy Complications
* Other: Quality-of-Life Assessment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>Patients receive standard home maintenance therapy and perform self-manual lymphatic drainage once daily for 60 minutes for 24 weeks. | Procedure: Management of Therapy Complications<br>* Receive standard home maintenance therapy and perform self-manual lymphatic drainage<br>* Other names: complications of therapy, management of;Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;|
| Experimental: Arm II<br>Patients receive Flexitouch® home maintenance therapy once daily for 60 minutes for 24 weeks | Procedure: Management of Therapy Complications<br>* Receive Flexitouch home maintenance therapy<br>* Other names: complications of therapy, management of;Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lower-extremity Volumes for Both Unaffected and Affected Legs | Volume for both lower extremities were going to be measured to determine if using the Flexi-touch was a more effective method to control lymphedema. Given that the study closed due to poor accrual (2 participants) analysis was not done. | From registration to study discontinuation. A maximum of 7 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life (QOL) and Functional Status as Assessed by the Lymphedema Questionnaire | Quality of life was to be assessed to compare QOL between arms. Due to poor accrual (2 participants) and study closure, data was not collected and analysis was not done. There are no results to report due to the limited number of participants. | From registration to study discontinuation. A maximum of 7 months. | 
| 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 | Compliance with treatment was to be measured between both arms of the study. Due to poor accrual (2 participants) and study closure, data was not collected and analysis was not done. There are no results to report due to the limited number of participants. | From registration to study discontinuation. A maximum of 7 months. | 
| Pain in Affected Limb | Pain in affected limb was to be measured. Due to poor accrual (2 participants) and study closure, data was not collected and analysis was not done. There are no results to report due to the limited number of participants. | From registration to study discontinuation. A maximum of 7 months. | 
| Incidence of Deep-vein Thrombosis | Incidence of deep-vein thrombosis was to be measured during the study. Unfortunately, due to low accrual study was closed. Analysis will not be performed. | From registration to study discontinuation. A maximum of 7 months. | 
| Incidence of Cellulitis | Incidence of cellulitis in both arms was planned to measured. Due to poor accrual (2 participants) and study closure, data was not collected and analysis was not done. There are no results to report due to the limited number of participants. | From registration to study discontinuation. A maximum of 7 months. | 
| Need for Unscheduled Visits at the Patients' Lymphedema Clinic | The need for unscheduled visits at the patient's lymphedema clinic was going to be analyzed. Due to poor accrual (2 participants) and study closure, data was not collected and analysis was not done. There are no results to report due to the limited number of participants. | From registration to study discontinuation. A maximum of 7 months. |