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

Lymphedema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00577317
• Other study ID #: GOG-0236
• Secondary ID: NCI-2009-00602CD
• Status: Terminated
• Phase: Phase 3
• Start date: December 2007
• Est. completion date: July 27, 2009

Study information

• Verified date: June 2021
• Source: GOG Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: July 27, 2009
• Est. primary completion date: July 27, 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• 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
• Uterine Cervical Neoplasms
• Vulvar Neoplasms

Intervention

Procedure:
• Management of Therapy Complications
Receive standard home maintenance therapy and perform self-manual lymphatic drainage
• Management of Therapy Complications
Receive Flexitouch home maintenance therapy

Other:
• Quality-of-Life Assessment
Ancillary studies

Locations

Country	Name	City	State
United States	Gynecologic Oncology Group	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Gynecologic Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.