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
NCT ID: NCT00577317
Last Updated: 2021-06-23
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
2 participants
INTERVENTIONAL
2007-12-31
2009-07-27
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Arm 1
Patients receive standard home maintenance therapy and perform self-manual lymphatic drainage once daily for 60 minutes for 24 weeks.
Management of Therapy Complications
Receive standard home maintenance therapy and perform self-manual lymphatic drainage
Quality-of-Life Assessment
Ancillary studies
Arm II
Patients receive Flexitouch® home maintenance therapy once daily for 60 minutes for 24 weeks
Management of Therapy Complications
Receive Flexitouch home maintenance therapy
Quality-of-Life Assessment
Ancillary studies
Interventions
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Management of Therapy Complications
Receive standard home maintenance therapy and perform self-manual lymphatic drainage
Management of Therapy Complications
Receive Flexitouch home maintenance therapy
Quality-of-Life Assessment
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion 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
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Gynecologic Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Levi Downs
Role: PRINCIPAL_INVESTIGATOR
Gynecologic Oncology Group
Locations
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Gynecologic Oncology Group
Philadelphia, Pennsylvania, United States
Countries
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Other Identifiers
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NCI-2009-00602
Identifier Type: REGISTRY
Identifier Source: secondary_id
CDR0000579834
Identifier Type: -
Identifier Source: secondary_id
GOG-0236
Identifier Type: OTHER
Identifier Source: secondary_id
GOG-0236
Identifier Type: OTHER
Identifier Source: secondary_id
GOG-0236
Identifier Type: OTHER
Identifier Source: secondary_id
GOG-0236
Identifier Type: -
Identifier Source: org_study_id
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