Gabapentin For the Control of Hot Flashes in Women With Breast Cancer
RATIONALE: Gabapentin may be effective for the control of hot flashes. It is not yet known if gabapentin is effective in treating hot flashes.
PURPOSE: Randomized clinical trial to study the effectiveness of gabapentin in controlling hot flashes in women who have breast cancer.
Procedure: quality-of-life assessment
|Study Design:||Allocation: Randomized
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Control of Vasomotor Symptoms in Women Treated for Breast Cancer|
|Study Start Date:||July 2001|
|Study Completion Date:||June 2005|
|Primary Completion Date:||June 2005 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00022074
|United States, Alabama|
|MBCCOP - Gulf Coast|
|Mobile, Alabama, United States, 36688|
|United States, Arizona|
|CCOP - Greater Phoenix|
|Phoenix, Arizona, United States, 85006-2726|
|CCOP - Scottsdale Oncology Program|
|Scottsdale, Arizona, United States, 85259-5404|
|United States, Colorado|
|CCOP - Colorado Cancer Research Program, Incorporated|
|Denver, Colorado, United States, 80224|
|United States, Hawaii|
|MBCCOP - Hawaii|
|Honolulu, Hawaii, United States, 96813|
|United States, Illinois|
|CCOP - Central Illinois|
|Decatur, Illinois, United States, 62526|
|United States, Kansas|
|CCOP - Wichita|
|Wichita, Kansas, United States, 67214-3882|
|United States, Michigan|
|CCOP - Kalamazoo|
|Kalamazoo, Michigan, United States, 49007-3731|
|United States, Minnesota|
|CCOP - Metro-Minnesota|
|Saint Louis Park, Minnesota, United States, 55416|
|United States, New Jersey|
|CCOP - Northern New Jersey|
|Hackensack, New Jersey, United States, 07601|
|United States, New York|
|CCOP - North Shore University Hospital|
|Manhasset, New York, United States, 11030|
|CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.|
|Syracuse, New York, United States, 13217|
|United States, North Carolina|
|CCOP - Southeast Cancer Control Consortium|
|Winston-Salem, North Carolina, United States, 27104-4241|
|United States, Ohio|
|CCOP - Columbus|
|Columbus, Ohio, United States, 43206|
|CCOP - Dayton|
|Dayton, Ohio, United States, 45429|
|United States, Washington|
|CCOP - Virginia Mason Research Center|
|Seattle, Washington, United States, 98101|
|CCOP - Northwest|
|Tacoma, Washington, United States, 98405-0986|
|United States, Wisconsin|
|CCOP - Marshfield Medical Research and Education Foundation|
|Marshfield, Wisconsin, United States, 54449|
|Study Chair:||Kishan J. Pandya, MD||James P. Wilmot Cancer Center|