Characterization of Chemotherapy/Biotherapy-Induced Peripheral Neuropathy: Refinement of Clinical Measures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Hearing as measured by the Weber test and the Rinne test at baseline, and then weeks 4, 8, and 12 during study treatment
研究概览
简要总结
RATIONALE: Learning about the effects of chemotherapy and biological therapy on nerve function may help doctors plan treatment and help patients live more comfortably.
PURPOSE: This clinical trial is studying peripheral neuropathy in patients who are receiving chemotherapy or biological therapy for cancer.
详细描述
OBJECTIVES:
- Determine the change in peripheral nerve function in cancer patients during and after treatment with chemotherapy or biologic therapy.
- Determine the clinical measurement of hearing-related air and bone conduction and vibratory sensation in these patients.
- Correlate the changes in orthostatic blood pressure using both the Vasotrac automated blood pressure device and the standard clinical automated blood pressure equipment.
- Determine the patient's perception of hearing quality before and after treatment with chemotherapy or biologic therapy.
OUTLINE: This is a multicenter study.
Patients undergo a 1-hour peripheral nerve function assessment, including hearing, vibratory sensation, and blood pressure testing, at baseline and then at 4, 8, and 12 weeks during treatment with chemotherapy or biologic therapy.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
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
- 21 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Hearing as measured by the Weber test and the Rinne test at baseline, and then weeks 4, 8, and 12 during study treatment
时间窗: baseline, and then weeks 4, 8, and 12 during study treatment
Vibratory sensation as measured by tuning fork at baseline, and then weeks 4, 8, and 12 during study treatment
时间窗: baseline, and then weeks 4, 8, and 12 during study treatment
Blood pressure changes at baseline, and then weeks 4, 8, and 12 during study treatment
时间窗: baseline, and then weeks 4, 8, and 12 during study treatment
次要结局
未报告次要终点