NCT04778878已完成不适用
Assessment of Chemotherapy-induced Peripheral Neurotoxicity Using a Point-of-care Nerve Conduction Study Device
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Nerve conductivity
研究概览
简要总结
The purpose of this study is to evaluate the feasibility of the Mediracer® NCS device in early detection of CIPN in patients receiving potentially neurotoxic substance (vincristine, oxaliplatin or docetaxel) as a part of their chemotherapy regimen.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Signed informed consent
- •Planned initiation of oxaliplatin-, vincristine- or docetaxel-containing chemotherapy regimen [FOLFOX, XELOX, (R)-CHOP/CHOEP/CVOP, docetaxel, docetaxel-doxorubicin]
- •Patient compliant with the study procedures
排除标准
- •Patient not fit/suitable for aforementioned chemotherapy regimen at baseline
- •Any prior postoperative or post-traumatic conditions affecting the sensory and/or motoric peripheral nerves
- •General vulnerability affecting the participation in the trial
结局指标
主要结局
Nerve conductivity
时间窗: 24 weeks
Nerve conductivity of n. medianus and ulnaris by Mediracer® NCS
Neuropathy related pain
时间窗: 24 weeks
Neuropathy related pain according to NPSI-assessment
Chemotherapy induced peripheral neuropathy (CIPN)
时间窗: 24 weeks
CIPN assessed by EORTC QLQ-CIPN20 questionnaire
Frequency of CIPN by CTCAE
时间窗: 24 weeks
Frequency of CIPN by CTCAE
次要结局
未报告次要终点
研究者
Jussi Koivunen
Consultant
Oulu University Hospital
研究点 (1)
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