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临床试验/NCT01208545
NCT01208545Unknown不适用

Serial Electrophysiologic Monitoring During Administration of Nerve-Toxic Chemotherapeutic Drugs

NeuroMetrix, Inc.1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2008年7月最近更新:
适应症

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

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

研究者

申办方类型
Industry

研究点 (1)

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