Breast Cancer Clinical Trial
Official title:
Control of Vasomotor Symptoms in Women Treated for 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.
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.
;
Allocation: Randomized, Masking: Open Label, Primary Purpose: Supportive Care
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