Serial Electrophysiologic Monitoring During Administration of Nerve-Toxic Chemotherapeutic Drugs
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Time in weeks to fifty percent decrease in sural nerve action potential amplitude
研究概览
简要总结
The study hypothesis is that changes in serially obtained nerve conduction study data obtained every 3-4 weeks in cancer patients receiving chemotherapy can be used to predict the development of a clinically significant / disabling drug induced neuropathy six and twelve months following the start of treatment. Patients with breast cancer, colon cancer, gastroesophageal cancer, and non-Hodgkins lymphoma will be enrolled. Six lower extremity nerves--three in each leg--will be electrically stimulated and their responses recorded at three to four week intervals coinciding with patient's scheduled chemotherapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of untreated breast cancer, treated (advance stage) or untreated colon cancer, untreated non-Hodgkins lymphoma, or advanced gastroesophageal cancer scheduled to begin chemotherapy with either Taxol, oxaliplatin, or vincristine
排除标准
- •Individuals with an implanted electronic medical devices (cardiac pacemaker or defibrillator, vagus nerve stimulator, deep brain stimulator, intrathecal pump, others)
- •Individuals whose chemotherapy regimen will include nerve toxic drugs other than Taxol, oxaliplatin, or vincristine, or includes more than one of these three drugs in combination
- •Individuals whose screening nerve conduction studies show peroneal motor amplitude < 1 mV bilaterally or sural sensory amplitude < 3 uV bilaterally or no result obtainable
结局指标
主要结局
Time in weeks to fifty percent decrease in sural nerve action potential amplitude
时间窗: one year
次要结局
未报告次要终点
