Dose Finding and Tolerability Study of Alpha-lipoic Acid in Patients at Risk for Paclitaxel Induced Peripheral Neuropathy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Identification of the Optimal Dose of ALA Based on Acceptable Adverse Event(AE) Profile
研究概览
简要总结
This study is being done because peripheral neuropathy, a condition that interrupts sensation in your limbs, is a common side effect of paclitaxel. There is some evidence that alpha lipoic acid (ALA), an antioxidant compound, protects neurons after exposure to paclitaxel. The purpose of this study is to assess the safety and tolerability of ALA and to find the best dose of ALA in patients that receive chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
Alpha lipoic acid
Oral administration three times daily (morning, mid-day, night)
干预措施: Alpha lipoic acid (Drug)
结局指标
主要结局
Identification of the Optimal Dose of ALA Based on Acceptable Adverse Event(AE) Profile
时间窗: 4 months
Based on acceptable adverse event (AE) profile and continual reassessment method dose escalation.
次要结局
- Proportion of Patients Who Complete the Proposed Regimen of Daily ALA(4 months)
- Cumulative Rate of Adverse Events(4 months)
- Total Neuropathy Score (TNS)(4 months)
研究者
Jeffrey Allen
Assistant Professor in Ken and Ruth Davee Department of Neurology
Northwestern University