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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):
GOG Foundation ( Gynecologic Oncology Group )

Study Description
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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.

Condition or disease Intervention/treatment Phase
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 Procedure: Management of Therapy Complications Other: Quality-of-Life Assessment Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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
Study Start Date : December 2007
Actual Primary Completion Date : July 2009

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Arms and Interventions
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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.
 Procedure: Management of Therapy Complications
Receive standard home maintenance therapy and perform self-manual lymphatic drainage
Other Name: complications of therapy, management of

Other: 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

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment


Outcome Measures
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Primary Outcome Measures :
  1. Lower-extremity volumes for both unaffected and affected legs [ Time Frame: Up to 24 weeks ]

Secondary Outcome Measures :
  1. Quality of life (QOL) and functional status as assessed by the Lymphedema Questionnaire [ Time Frame: Up to 24 weeks ]
  2. 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 ]
  3. Pain in affected limb [ Time Frame: Up to 24 weeks ]
  4. Incidence of deep-vein thrombosis [ Time Frame: Up to 24 weeks ]
  5. Incidence of cellulitis [ Time Frame: Up to 24 weeks ]
  6. Need for unscheduled visits at the patients' lymphedema clinic [ Time Frame: Up to 24 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00577317


Locations
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United States, Pennsylvania
Gynecologic Oncology Group
Philadelphia, Pennsylvania, United States, 19103
Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Levi Downs Gynecologic Oncology Group
More Information
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Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00577317    
Other Study ID Numbers: 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 )
First Posted: December 20, 2007    Key Record Dates
Last Update Posted: December 31, 2014
Last Verified: December 2014
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Vulvar Neoplasms
Lymphedema
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Lymphatic Diseases
Vulvar Diseases