NCT01466270已完成2 期
A Feasibility Study of Donepezil in Female Breast Cancer Survivors With Self-Reported Cognitive Dysfunction Following Chemotherapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 62
- 主要终点
- Retention
研究概览
简要总结
RATIONALE: Donepezil hydrochloride may help lessen cognitive dysfunction caused by chemotherapy.
PURPOSE: This phase II trial is studying donepezil hydrochloride in treating cognitive dysfunction after chemotherapy in female breast cancer survivors.
详细描述
OBJECTIVES:
Primary
- Determine the feasibility of conducting a randomized placebo-controlled clinical trial for cognitive symptoms in female breast cancer survivors.
Secondary
- Estimate the variability of the clinical outcomes (FACT-Cognition Perceived Cognitive Impairment subscale, neurocognitive battery, FACIT-Fatigue, FACT Cog Total Score, PROMIS Fatigue, Epworth Sleepiness Scale, Beck Depression Inventory, Beck Anxiety Inventory, and RAND Short Form-36).
- Estimate the within patient correlation over time of the clinical outcomes.
- Obtain preliminary estimates of the effect of donepezil on the primary and secondary outcome variables.
- Correlate the reports of fatigue, sleep disturbance, and mood with measures of cognitive symptoms and neurocognitive test performance.
- Document the severity of cognitive symptoms and functional impairment in female breast cancer survivors who enroll on this pilot study.
- Correlate cognitive symptoms with cognitive test performance.
- Document the toxicities associated with donepezil hydrochloride use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm I
Experimental
Patients receive donepezil hydrochloride PO QD.
干预措施: donepezil hydrochloride (Drug)
Arm II
Placebo Comparator
Patients receive placebo PO QD.
干预措施: Placebo (Drug)
结局指标
主要结局
Retention
时间窗: 24 Weeks
Retention is the percentage of participants who stay in the study for 24 weeks.
Compliance
时间窗: 24 weeks
Compliance is the percentage of pills taken while on study (based on returned diaries)
次要结局
- HVLT-IR(24 weeks)
- Fatigue(24 weeks)
研究者
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