Control of Vasomotor Symptoms in Women Treated for Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Gary Morrow
- 试验地点
- 18
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- — 至 120 Years（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of breast cancer
- •Experiencing 2 or more hot flashes per day for at least 1 week
- •Hormone receptor status:
- •Not specified
- •PATIENT CHARACTERISTICS:
- •Not specified
- •Menopausal status:
- •Not specified
- •Performance status:
- •Not specified
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Not specified
- •Bilirubin normal
- •SGOT no greater than 2 times upper limit of normal (ULN)
- •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
- •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
- •Not specified
- •No other concurrent anticonvulsant medication
- •No concurrent clonidine or venlafaxine
排除标准
- 未提供
研究者
Gary Morrow
Director, University of Rochester NCORP Research Base
University of Rochester NCORP Research Base