Control of Vasomotor Symptoms in Women Treated for Breast Cancer
- 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
- Compare quality of life, anxiety, and depression in patients treated with these
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.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Supportive Care
Kishan J. Pandya, MD
James P. Wilmot Cancer Center
United States: Federal Government
|MBCCOP - Hawaii||Honolulu, Hawaii 96813|
|CCOP - Wichita||Wichita, Kansas 67214-3882|
|CCOP - Greater Phoenix||Phoenix, Arizona 85006-2726|
|CCOP - North Shore University Hospital||Manhasset, New York 11030|
|CCOP - Southeast Cancer Control Consortium||Winston-Salem, North Carolina 27104-4241|
|CCOP - Kalamazoo||Kalamazoo, Michigan 49007-3731|
|CCOP - Metro-Minnesota||Saint Louis Park, Minnesota 55416|
|CCOP - Northern New Jersey||Hackensack, New Jersey 07601|
|CCOP - Scottsdale Oncology Program||Scottsdale, Arizona 85259-5404|
|CCOP - Central Illinois||Springfield, Illinois 62526|
|CCOP - Columbus||Columbus, Ohio 43206|
|CCOP - Dayton||Kettering, Ohio 45429|
|CCOP - Marshfield Medical Research and Education Foundation||Marshfield, Wisconsin 54449|
|MBCCOP - Gulf Coast||Mobile, Alabama 36688|
|CCOP - Virginia Mason Research Center||Seattle, Washington 98101|
|CCOP - Northwest||Tacoma, Washington 98405-0986|
|CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.||Syracuse, New York 13217|
|CCOP - Colorado Cancer Research Program, Incorporated||Denver, Colorado 80224|