Gabapentin For the Control of Hot Flashes in Women With Breast Cancer
- Conditions
- Anxiety DisorderBreast CancerDepressionHot Flashes
- Registration Number
- NCT00022074
- Lead Sponsor
- Gary Morrow
- Brief Summary
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.
- Detailed Description
OBJECTIVES:
* 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (18)
CCOP - Metro-Minnesota
🇺🇸Saint Louis Park, Minnesota, United States
CCOP - Northern New Jersey
🇺🇸Hackensack, New Jersey, United States
MBCCOP - Gulf Coast
🇺🇸Mobile, Alabama, United States
CCOP - Kalamazoo
🇺🇸Kalamazoo, Michigan, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
🇺🇸Syracuse, New York, United States
CCOP - North Shore University Hospital
🇺🇸Manhasset, New York, United States
CCOP - Virginia Mason Research Center
🇺🇸Seattle, Washington, United States
CCOP - Colorado Cancer Research Program, Incorporated
🇺🇸Denver, Colorado, United States
CCOP - Scottsdale Oncology Program
🇺🇸Scottsdale, Arizona, United States
CCOP - Greater Phoenix
🇺🇸Phoenix, Arizona, United States
MBCCOP - Hawaii
🇺🇸Honolulu, Hawaii, United States
CCOP - Central Illinois
🇺🇸Decatur, Illinois, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
CCOP - Dayton
🇺🇸Dayton, Ohio, United States
CCOP - Southeast Cancer Control Consortium
🇺🇸Winston-Salem, North Carolina, United States
CCOP - Northwest
🇺🇸Tacoma, Washington, United States
CCOP - Columbus
🇺🇸Columbus, Ohio, United States
CCOP - Marshfield Medical Research and Education Foundation
🇺🇸Marshfield, Wisconsin, United States