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.
(Withdrawn due to poor accrual and lack of feasibility)
Sponsor:
Gynecologic Oncology Group
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00577317
First received: December 19, 2007
Last updated: August 3, 2009
Last verified: July 2009
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Purpose
RATIONALE: 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.
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cervical Cancer Endometrial Cancer Lymphedema Vulvar Cancer |
Procedure: management of therapy complications Procedure: quality-of-life assessment |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized 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 National Cancer Institute (NCI):
Primary Outcome Measures:
- Lower-extremity volumes for both unaffected and affected legs [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Quality of life (QOL) and functional status [ Designated as safety issue: No ]
- Pain in affected limb [ Designated as safety issue: Yes ]
- Deep-vein thrombosis [ Designated as safety issue: Yes ]
- Cellulitis [ Designated as safety issue: Yes ]
- Need for unscheduled visits at the patients' lymphedema clinic [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 262 |
| Study Start Date: | December 2007 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
- 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
- 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.
Tertiary
- Correlate changes in limb volume to changes in QOL outcomes in order to produce an estimate of a clinically meaningful change in limb volume for use in future studies.
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
DISEASE CHARACTERISTICS:
- Diagnosis of unilateral lower-extremity lymphedema as a result of surgery, chemotherapy, and/or radiation therapy for cervical, vulvar, or endometrial cancer
- Prior to acute clinic therapy, the affected limb edema must have been greater than stage I and must have had at least a 10% excess volume over the unaffected limb
- No clinic therapy for lower-extremity lymphedema for 6 months prior to the start of the patient's acute clinic therapy
- Must be within 3 years from the completion of therapy for original gynecologic cancer diagnosis
- At the time of completion of acute clinic therapy, patients must have reached their nadir limb volume for two consecutive measurements each 7-10 days apart
- No known active or recurrent cancer
PATIENT CHARACTERISTICS:
- GOG performance status 0-2
- Not pregnant
- No history of peripheral vascular disease (venous or arterial), pulmonary edema, congestive heart failure, or chronic renal disease
- No current diagnosis of deep-vein thrombosis or phlebitis in the affected limb
- No open wound(s) or active infection of the affected limb
- No history of chronic lower-extremity lymphoma that predates cancer diagnosis
- No poorly controlled asthma
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- More than 3 months since prior cancer treatment
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00577317
Locations
| United States, Connecticut | |
| George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus | |
| New Britain, Connecticut, United States, 06050 | |
| United States, Illinois | |
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | |
| Chicago, Illinois, United States, 60611-3013 | |
| United States, Ohio | |
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | |
| Columbus, Ohio, United States, 43210-1240 | |
| United States, Oklahoma | |
| Oklahoma University Cancer Institute | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| Cancer Care Associates - Saint Francis Campus | |
| Tulsa, Oklahoma, United States, 74136-1929 | |
| United States, Rhode Island | |
| Women and Infants Hospital of Rhode Island | |
| Providence, Rhode Island, United States, 02905 | |
| United States, South Carolina | |
| Hollings Cancer Center at Medical University of South Carolina | |
| Charleston, South Carolina, United States, 29425 | |
| United States, Virginia | |
| Carilion Gynecologic Oncology Associates | |
| Roanoke, Virginia, United States, 24014 | |
| United States, Wisconsin | |
| Aurora Women's Pavilion of West Allis Memorial Hospital | |
| West Allis, Wisconsin, United States, 53227 | |
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
| Study Chair: | Levi S. Downs, MD | Masonic Cancer Center, University of Minnesota |
More Information
No publications provided
| Responsible Party: | Philip J. DiSaia, Gynecologic Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00577317 History of Changes |
| Other Study ID Numbers: | CDR0000579834, GOG-0236 |
| Study First Received: | December 19, 2007 |
| Last Updated: | August 3, 2009 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
lymphedema stage 0 cervical cancer stage IA cervical cancer stage IB cervical cancer stage IIA cervical cancer stage IIB cervical cancer stage III cervical cancer stage IVA cervical cancer stage IVB cervical cancer stage 0 endometrial carcinoma |
stage I endometrial carcinoma stage II endometrial carcinoma stage III endometrial carcinoma stage IV endometrial carcinoma stage 0 vulvar cancer stage I vulvar cancer stage II vulvar cancer stage III vulvar cancer stage IV vulvar cancer |
Additional relevant MeSH terms:
|
Endometrial Neoplasms Sarcoma, Endometrial Stromal Uterine Cervical Neoplasms Lymphedema Vulvar Neoplasms Adenoma Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms |
Uterine Diseases Genital Diseases, Female Neoplasms, Complex and Mixed Neoplasms by Histologic Type Sarcoma Neoplasms, Connective and Soft Tissue Endometrial Stromal Tumors Uterine Cervical Diseases Lymphatic Diseases Vulvar Diseases Neoplasms, Glandular and Epithelial |
ClinicalTrials.gov processed this record on June 18, 2013