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
Verified date | June 2021 |
Source | GOG Foundation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Gynecologic Oncology Group | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Gynecologic Oncology Group | National Cancer Institute (NCI) |
United States,
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. |
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