Transauricular Vagus Nerve Stimulation in the Treatment of Chemotherapy-induced Peripheral Neuropathy: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- NRS(numerical rating scale)
研究概览
简要总结
Chemotherapy induced peripheral neuropathy is common in tumor patients receiving chemotherapy. Nowaday, CIPN is mainly treated with drugs, but the therapeutic effect is not satisfactory. Previous studies have found that inflammatory immune mechanism plays an important role in neuropathic pain. Vagus nerve stimulation can not only relieve pain by regulating the autonomic nervous system, but also participate in the immune response. Investigators hope that the treatment by vagus nerve electrical stimulation through ear skin can improve the pain and neurotoxicity scores of CIPN patient.If it is proved that vagus nerve stimulation can effectively treat CIPN, it will become a simple and safe non-drug treatment which has good application prospects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is currently receiving chemotherapy drugs with neurotoxicity
- •New or worsening numbness and / or pain in the hands and / or feet, and no other cause explains the above symptoms
排除标准
- •Patients with sinus bradycardia, long QT syndrome, sick sinus syndrome or other arrhythmias, mental diseases, cardiac pacemakers or other electrical stimulation devices after implantation.
- •Patients taking analgesics due to pain in other parts of the body.
结局指标
主要结局
NRS(numerical rating scale)
时间窗: Day90
0-10，0 =no pain, 10 = the most severe pain.
次要结局
- QST( Quantitative Sensory Testing)(Day1,Day14)
- SF-12，Short From health survey -12(Day1,Day8,Day14,Day30,Day60,Day90)
- NCI-CTC v4.0 neurotoxicity classification(Day1,Day3,Day5,Day8,Day14,Day30,Day60,Day90)
- IL-2，IL-4，IL-6，IL-10，IFN-γ，TNF-α(Day1,Day14)
- Athens insomnia scale(Day1,Day8,Day14,Day30,Day60,Day90)
研究者
Yi Feng, MD
director of department of Anesthesiology and Pain medicine
Peking University People's Hospital