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

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Brief Title

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

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

Brief 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.
    

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 Phase

Phase 3

Study Type

Interventional


Primary Outcome

Lower-extremity Volumes for Both Unaffected and Affected Legs

Secondary Outcome

 Quality of Life (QOL) and Functional Status as Assessed by the Lymphedema Questionnaire

Condition

Lymphedema

Intervention

Management of Therapy Complications

Study Arms / Comparison Groups

 Arm 1
Description:  Patients receive standard home maintenance therapy and perform self-manual lymphatic drainage once daily for 60 minutes for 24 weeks.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

2

Start Date

December 2007

Completion Date

July 27, 2009

Primary Completion Date

July 27, 2009

Eligibility Criteria

        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
      

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Levi Downs, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00577317

Organization ID

GOG-0236

Secondary IDs

NCI-2009-00602

Responsible Party

Sponsor

Study Sponsor

Gynecologic Oncology Group

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Levi Downs, Principal Investigator, Gynecologic Oncology Group


Verification Date

June 2021