A Pilot Study Using Ultrasound for the Detection of Oxaliplatin-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 Comparison
研究概览
简要总结
This pilot clinical trial studies how well ultrasound works in detecting oxaliplatin-induced neuropathy in participants with gastrointestinal cancer. Ultrasound may work better in diagnosing and detecting neuropathy in gastrointestinal cancer participants treated with the chemotherapy drug called oxaliplatin.
详细描述
Primary Objectives
I. To compare tibial motor nerve ultrasound cross-sectional area between oxaliplatin-induced peripheral neuropathy patients and historical data among healthy adults.
and oxaliplatin-induced peripheral neuropathy patients
II. To compare sural sensory nerve ultrasound cross-sectional area between oxaliplatin-induced peripheral neuropathy patients and historical data among healthy adults and oxaliplatin-induced peripheral neuropathy patients
Secondary Objectives
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
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any gastrointestinal cancer including colon, rectal, colorectal, pancreas, esophageal, or other (any stage)
- •Previously or currently receiving oxaliplatin -based chemotherapy.
- •Clinical symptoms of peripheral neuropathy noted in medical record and suspected to be secondary to oxaliplatin -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 oxaliplatin chemotherapy.
- •Unable to provide history.
研究组 & 干预措施
Ultrasound
Undergo peripheral nerve ultrasound
干预措施: Ultrasound - Serial and Tibial Nerve (Diagnostic Test)
Ultrasound
Undergo peripheral nerve ultrasound
干预措施: Blood draw (Other)
Ultrasound
Undergo peripheral nerve ultrasound
干预措施: QLQ-CIPN20 Questionnaire Administration (Other)
Ultrasound
Undergo peripheral nerve ultrasound
干预措施: Abbreviated Neurologic Exam (Other)
Ultrasound
Undergo peripheral nerve ultrasound
干预措施: Nerve Conduction Study (Diagnostic Test)
Ultrasound
Undergo peripheral nerve ultrasound
干预措施: Skin Biopsy (Procedure)
结局指标
主要结局
Tibial Nerve Cross-Sectional Area Comparison
时间窗: Up to 30 days
Tibial nerve cross-sectional area determined by ultrasound in oxaliplatin-induced peripheral neuropathy patients will be transformed to compare to historical data previously collected from healthy adults and oxaliplatin-induced peripheral neuropathy patients using analysis of variance (ANOVA).
次要结局
- Amplitude of Nerve Response of Sural Nerve(Up to 30 days)
- Sural Nerve Cross-Sectional Area Comparison(Up to 30 days)
- Amplitude of Nerve Response of Tibial Nerve(Up to 30 days)
- Distal Latency of Nerve Response of Tibial Nerve(Up to 30 days)
- Distal Latency of Nerve Response of Sural Nerve(Up to 30 days)
- Conduction Velocity of Nerve Response of Tibial Nerve(Up to 30 days)
- Conduction Velocity of Nerve Response of Sural Nerve(Up to 30 days)
- Reduction of Intraepidermal Nerve Fiber Density(Up to 30 days)
- European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Chemotherapy-Induced Peripheral Neuropathy 20 (EORTC QLQ-CIPN20) Questionnaire(Up to 30 days)