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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
2
Receive standard home maintenance therapy and perform self-manual lymphatic drainage
Receive Flexitouch home maintenance therapy
Ancillary studies
Gynecologic Oncology Group
Philadelphia, Pennsylvania, United States
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.
Time frame: From registration to study discontinuation. A maximum of 7 months.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From registration to study discontinuation. A maximum of 7 months.
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