Gabapentin For the Control of Hot Flashes in Women With Breast Cancer
NCT ID: NCT00022074
Last Updated: 2015-10-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
INTERVENTIONAL
2001-07-31
2005-06-30
Brief Summary
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PURPOSE: Randomized clinical trial to study the effectiveness of gabapentin in controlling hot flashes in women who have breast cancer.
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Detailed Description
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* Compare the effectiveness and side effects of 2 different doses of gabapentin vs placebo for the control of hot flashes and other vasomotor symptoms in women with breast cancer.
* Compare quality of life, anxiety, and depression in patients treated with these regimens.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to participating center and duration of hot flash symptoms (less than 9 months vs 9 or more months). Patients are randomized to 1 of 3 arms.
* Arm I: Patients receive oral placebo 3 times a day.
* Arm II: Patients receive oral gabapentin at a low dose 3 times a day.
* Arm III: Patients receive oral gabapentin as in arm II for 3 days and then at a high dose 3 times a day.
Treatment on all arms continues for 8 weeks in the absence of unacceptable toxicity. After week 8, patients may receive open-label gabapentin at the discretion of their physicians.
Hot flashes are assessed at baseline and then during weeks 3 and 7 of the study.
Quality of life, anxiety, and depression are assessed at baseline and then at weeks 4 and 8.
Patients are followed at week 12.
PROJECTED ACCRUAL: A total of 408 patients (136 per arm) will be accrued for this study within 18 months.
Conditions
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Study Design
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RANDOMIZED
SUPPORTIVE_CARE
NONE
Interventions
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gabapentin
quality-of-life assessment
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of breast cancer
* Experiencing 2 or more hot flashes per day for at least 1 week
* Hormone receptor status:
* Not specified
PATIENT CHARACTERISTICS:
Age:
* Not specified
Sex:
* Female
Menopausal status:
* Not specified
Performance status:
* Not specified
Life expectancy:
* Not specified
Hematopoietic:
* Not specified
Hepatic:
* Bilirubin normal
* SGOT no greater than 2 times upper limit of normal (ULN)
Renal:
* Creatinine no greater than 1.25 times ULN
Cardiovascular:
* No coronary insufficiency
* No myocardial infarction within the past 3 months
* No symptomatic cardiac disease
* No peripheral vascular disease
* No cerebrovascular disease or stroke
* No syncope or symptomatic hypotension
Other:
* No history of allergic or other adverse reaction to gabapentin
* Not pregnant or nursing
* Fertile patients must use effective contraception during and for 1 week after study
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* Not specified
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* Not specified
Other
* No other concurrent anticonvulsant medication
* No concurrent clonidine or venlafaxine
120 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Gary Morrow
OTHER
Responsible Party
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Gary Morrow
Director, University of Rochester NCORP Research Base
Principal Investigators
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Kishan J. Pandya, MD
Role: STUDY_CHAIR
James P. Wilmot Cancer Center
Locations
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MBCCOP - Gulf Coast
Mobile, Alabama, United States
CCOP - Greater Phoenix
Phoenix, Arizona, United States
CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, United States
CCOP - Colorado Cancer Research Program, Incorporated
Denver, Colorado, United States
MBCCOP - Hawaii
Honolulu, Hawaii, United States
CCOP - Central Illinois
Decatur, Illinois, United States
CCOP - Wichita
Wichita, Kansas, United States
CCOP - Kalamazoo
Kalamazoo, Michigan, United States
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States
CCOP - Northern New Jersey
Hackensack, New Jersey, United States
CCOP - North Shore University Hospital
Manhasset, New York, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, United States
CCOP - Southeast Cancer Control Consortium
Winston-Salem, North Carolina, United States
CCOP - Columbus
Columbus, Ohio, United States
CCOP - Dayton
Dayton, Ohio, United States
CCOP - Virginia Mason Research Center
Seattle, Washington, United States
CCOP - Northwest
Tacoma, Washington, United States
CCOP - Marshfield Medical Research and Education Foundation
Marshfield, Wisconsin, United States
Countries
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References
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Pandya KJ, Morrow GR, Roscoe JA, Zhao H, Hickok JT, Pajon E, Sweeney TJ, Banerjee TK, Flynn PJ. Gabapentin for hot flashes in 420 women with breast cancer: a randomised double-blind placebo-controlled trial. Lancet. 2005 Sep 3-9;366(9488):818-24. doi: 10.1016/S0140-6736(05)67215-7.
Other Identifiers
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URCC-U2101
Identifier Type: -
Identifier Source: secondary_id
NCI-P01-0183
Identifier Type: -
Identifier Source: secondary_id
CDR0000068780
Identifier Type: -
Identifier Source: org_study_id
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