A Pilot Study Using Ultrasound for the Detection of Taxane-Induced Peripheral Neuropathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Tibial Nerve Cross-sectional Area
研究概览
简要总结
This pilot clinical trial studies how well ultrasound works in detecting taxane-induced neuropathy in patients with breast cancer. Ultrasound may work better in diagnosing and detecting neuropathy in breast cancer patients treated with the chemotherapy drug called a taxane.
详细描述
PRIMARY OBJECTIVES:
I. To compare tibial motor nerve ultrasound cross-sectional area (CSA) between taxane-induced peripheral neuropathy (TIPN) patients and historical data among healthy adults.
SECONDARY OBJECTIVES:
I. To compare sural sensory nerve ultrasound CSA between TIPN patients and historical data among healthy adults.
II. To determine if the above changes in nerve CSA correlate with NCS changes in the same TIPN patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Breast cancer (any stage)
- •Previously or currently receiving taxane-based chemotherapy
- •Clinical symptoms of peripheral neuropathy noted in medical record and suspected to be secondary to taxane-based therapy
- •Ability and willingness to understand and sign an informed consent
排除标准
- •Self-reported or documented history of pre-existing peripheral neuropathy prior to initiation of taxane chemotherapy
- •Unable to provide history
结局指标
主要结局
Tibial Nerve Cross-sectional Area
时间窗: Up to 30 days
Will be determined by ultrasound in the tibial nerve. Will be compared to the historical data from healthy patients using two-sample t-test (two-sample t-test selected as primary data from the historical control patients is available and will be used for analysis). Will also compare the nerve cross-sectional area in our study sample to that in the historical diabetic neuropathy patients and historical oxaliplatin neuropathy patients using one-sample t-test. The general linear model will be used to evaluate any factors (e.g., age) that may be associated with the nerve cross-sectional area. Due
次要结局
- Conduction Velocity of Nerve Response - Tibial(Up to 30 days)
- Distal Latency of Nerve Response - Ankle(Up to 30 days)
- Nerve Fiber Density in the Skin(Up to 30 days)
- Sural Nerve Cross-sectional Area(Up to 30 days)
- Amplitude of Nerve Response - Ankle(Up to 30 days)
- Self-reported Neuropathy Score(Up to 30 days)