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

This study has been terminated.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00577317
First received: December 19, 2007
Last updated: February 26, 2014
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Lymphedema
Stage 0 Cervical Cancer
Stage 0 Endometrial Carcinoma
Stage 0 Vulvar Cancer
Stage I Endometrial Carcinoma
Stage I Vulvar Cancer
Stage IA Cervical Cancer
Stage IB Cervical Cancer
Stage II Endometrial Carcinoma
Stage II Vulvar Cancer
Stage IIA Cervical Cancer
Stage IIB Cervical Cancer
Stage III Cervical Cancer
Stage III Endometrial Carcinoma
Stage III Vulvar Cancer
Stage IV Endometrial Carcinoma
Stage IVA Cervical Cancer
Stage IVB Cervical Cancer
Stage IVB Vulvar Cancer
Procedure: management of therapy complications
Procedure: quality-of-life assessment
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Supportive Care
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

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Group:

Primary Outcome Measures:
  • Lower-extremity volumes for both unaffected and affected legs [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life (QOL) and functional status as assessed by the Lymphedema Questionnaire [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]
  • 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: Up to 24 weeks ] [ Designated as safety issue: No ]
  • Pain in affected limb [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: Yes ]
  • Incidence of deep-vein thrombosis [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: Yes ]
  • Incidence of cellulitis [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: Yes ]
  • Need for unscheduled visits at the patients' lymphedema clinic [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 2
Study Start Date: December 2007
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Patients receive standard home maintenance therapy and perform self-manual lymphatic drainage once daily for 60 minutes for 24 weeks.
Procedure: management of therapy complications
Receive standard home maintenance therapy and perform self-manual lymphatic drainage
Other Name: complications of therapy, management of
Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Experimental: Arm II
Patients receive Flexitouch® home maintenance therapy once daily for 60 minutes for 24 weeks
Procedure: management of therapy complications
Receive Flexitouch home maintenance therapy
Other Name: complications of therapy, management of
Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00577317

Locations
United States, Pennsylvania
Gynecologic Oncology Group
Philadelphia, Pennsylvania, United States, 19103
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Principal Investigator: Levi Downs Gynecologic Oncology Group
  More Information

No publications provided

Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00577317     History of Changes
Other Study ID Numbers: GOG-0236, NCI-2009-00602, CDR0000579834, GOG-0236, GOG-0236, GOG-0236, U10CA101165
Study First Received: December 19, 2007
Last Updated: February 26, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma
Uterine Cervical Neoplasms
Lymphedema
Vulvar Neoplasms
Endometrial Neoplasms
Cervical Intraepithelial Neoplasia
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Lymphatic Diseases
Vulvar Diseases
Carcinoma in Situ

ClinicalTrials.gov processed this record on April 17, 2014