Impact of Treatment With Taxane or Platinum-Containing Regimens on Peripheral Nerve Functioning in Older Cancer Patients With Diabetes: An Exploratory Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Cutaneous sensation as measured by Semmes-Weinstein monofilaments
研究概览
简要总结
RATIONALE: Learning about the side effects of chemotherapy may help plan treatment and may help patients live more comfortably.
PURPOSE: This clinical trial is studying nerve function in older diabetic patients who are undergoing chemotherapy for metastatic solid tumors.
详细描述
OBJECTIVES:
Primary
- Determine changes in peripheral nerve function in older patients with diabetes and metastatic solid tumors treated with taxane or platinum-containing chemotherapy regimens.
- Determine the extent to which age, pre-existing diabetes mellitus, and level of glycemic control predict a differential pattern in outcome beyond the effect of the drugs in patients treated with these regimens.
- Develop a clinical assessment that would predict whether or not patients with diabetes mellitus are more or less susceptible to the neurotoxic effects of chemotherapy.
OUTLINE: This is a longitudinal study.
Patients undergo an interview and clinical evaluation to measure demographic data, cutaneous sensation, gait and balance, vibration, lower extremity muscle strength, orthostatic blood pressure, and glycemic control. Patients are evaluated at baseline, every 3 weeks during chemotherapy for up to 4 treatments, and at 2 months after completion of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（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
Cutaneous sensation as measured by Semmes-Weinstein monofilaments
时间窗: baseline, every 3 weeks for 4 courses, and then 2 months after completion of study treatment
Gait and balance as measured by Tinetti Performance Oriented Assessment of Gait and Balance Instrument
时间窗: baseline, every 3 weeks for 4 courses, and then 2 months after completion of study treatment
Vibration as measured by tuning fork
时间窗: baseline, every 3 weeks for 4 courses, and then 2 months after completion of study treatment
Lower extremity muscle strength as measured by Dynamometer
时间窗: baseline, every 3 weeks for 4 courses, and then 2 months after completion of study treatment
Blood pressure changes
时间窗: baseline, every 3 weeks for 4 courses, and then 2 months after completion of study treatment
Glycemic control as measured by Glycosylated Hemoglobin Assay
时间窗: baseline, every 3 weeks for 4 courses, and then 2 months after completion of study treatment
次要结局
未报告次要终点