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

June 11, 2021 updated by: Gynecologic Oncology Group

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19103
        • Gynecologic Oncology Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lower-extremity Volumes for Both Unaffected and Affected Legs
Time Frame: From registration to study discontinuation. A maximum of 7 months.
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
Time Frame: From registration to study discontinuation. A maximum of 7 months.
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
Time Frame: From registration to study discontinuation. A maximum of 7 months.
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
Time Frame: From registration to study discontinuation. A maximum of 7 months.
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
Time Frame: From registration to study discontinuation. A maximum of 7 months.
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
Time Frame: From registration to study discontinuation. A maximum of 7 months.
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
Time Frame: From registration to study discontinuation. A maximum of 7 months.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gynecologic Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Levi Downs, Gynecologic Oncology Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

July 27, 2009

Study Completion (Actual)

July 27, 2009

Study Registration Dates

First Submitted

December 19, 2007

First Submitted That Met QC Criteria

December 19, 2007

First Posted (Estimate)

December 20, 2007

Study Record Updates

Last Update Posted (Actual)

June 23, 2021

Last Update Submitted That Met QC Criteria

June 11, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GOG-0236 (Other Identifier: CTEP)
  • NCI-2009-00602 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • CDR0000579834
  • U10CA101165 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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