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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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ClinicalTrials.gov Identifier: NCT00577317
Recruitment Status : Terminated
First Posted : December 20, 2007
Last Update Posted : December 31, 2014
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gynecologic Oncology Group

Tracking Information
First Submitted Date  ICMJE December 19, 2007
First Posted Date  ICMJE December 20, 2007
Last Update Posted Date December 31, 2014
Study Start Date  ICMJE December 2007
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 26, 2014)
Lower-extremity volumes for both unaffected and affected legs [ Time Frame: Up to 24 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 19, 2007)
  • Comparison of effectiveness of Flexitouch® vs standard home lymphedema therapy
  • Lower-extremity volumes for both unaffected and affected legs
Change History Complete list of historical versions of study NCT00577317 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 26, 2014)
  • Quality of life (QOL) and functional status as assessed by the Lymphedema Questionnaire [ Time Frame: Up to 24 weeks ]
  • 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 ]
  • Pain in affected limb [ Time Frame: Up to 24 weeks ]
  • Incidence of deep-vein thrombosis [ Time Frame: Up to 24 weeks ]
  • Incidence of cellulitis [ Time Frame: Up to 24 weeks ]
  • Need for unscheduled visits at the patients' lymphedema clinic [ Time Frame: Up to 24 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 19, 2007)
  • Quality of life (QOL) and functional status
  • Correlation of changes in limb volume to changes in QOL
  • Pain in affected limb
  • Deep-vein thrombosis
  • Cellulitis
  • Need for unscheduled visits at the patients' lymphedema clinic
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Condition  ICMJE
  • 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
Intervention  ICMJE
  • Procedure: Management of Therapy Complications
    Receive standard home maintenance therapy and perform self-manual lymphatic drainage
    Other Name: complications of therapy, management of
  • Procedure: Management of Therapy Complications
    Receive Flexitouch home maintenance therapy
    Other Name: complications of therapy, management of
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other Name: Quality of Life Assessment
Study Arms  ICMJE
  • Experimental: Arm 1
    Patients receive standard home maintenance therapy and perform self-manual lymphatic drainage once daily for 60 minutes for 24 weeks.
    Interventions:
    • Procedure: Management of Therapy Complications
    • Other: Quality-of-Life Assessment
  • Experimental: Arm II
    Patients receive Flexitouch® home maintenance therapy once daily for 60 minutes for 24 weeks
    Interventions:
    • Procedure: Management of Therapy Complications
    • Other: Quality-of-Life Assessment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 26, 2014)
2
Original Enrollment  ICMJE
 (submitted: December 19, 2007)
262
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00577317
Other Study ID Numbers  ICMJE GOG-0236
NCI-2009-00602 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000579834
GOG-0236 ( Other Identifier: Gynecologic Oncology Group )
GOG-0236 ( Other Identifier: DCP )
GOG-0236 ( Other Identifier: CTEP )
U10CA101165 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gynecologic Oncology Group
Study Sponsor  ICMJE Gynecologic Oncology Group
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Levi Downs Gynecologic Oncology Group
PRS Account Gynecologic Oncology Group
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP