Lu Chao, Bao Wenlong, Deng Dehou, Li Rongrong, Li Guangliang, Zou Shanlin, Wang Yan
The Traditional Chinese Medicine Department, The Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Hangzhou, China.
The Third Clinical Medical College, Zhejiang University of Traditional Chinese Medicine, Hangzhou, China.
Front Neurol. 2022 Jul 28;13:843886. doi: 10.3389/fneur.2022.843886. eCollection 2022.
Chemotherapy-induced peripheral neuropathy (CIPN) is a common complication in patients with cancer during chemotherapy. It mainly leads to severe numbness of the hands and feet and causes great pain in patients. Electroacupuncture (EA) is considered to be beneficial in improving peripheral neuropathy and relieving numbness of the hands and feet. This trial aims to evaluate the therapeutic effect of different frequencies of EA on CIPN in patients with cancer.
This study is a randomized controlled trial. In total, 160 eligible CIPN patients are randomly assigned to the 2 Hz EA group, 100 Hz EA group, 2/100 Hz EA group, and control group in the ratio of 1:1:1:1. All patients in the EA treatment groups receive treatment with EA three times a week for 4 weeks and following up for 4 weeks. The patients in the control group are given Mecobalamin (MeCbl) tablets orally, one tablet at a time, three times a day, for 4 weeks, and following up for 4 weeks. The primary outcome measures are the participant neurotoxicity questionnaire (PNQ) and the peripheral neurotoxicity assessment rating (NCI CTCAE V5.0). Secondary outcomes are the quality of life scale (EORTC QLQ-C30) and the measurement of peripheral nerve conduction velocity (NCV). The results are evaluated at baseline, post-treatment phase, and following up for 4 weeks. All major analyses are based on the intention to treat principle.
ETHICS/DISSEMINATION: This protocol was approved by the Medical Ethics Committee of the Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital) on 7 December 2021. The license number is IRB-2021-458. This study provides clinical efficacy data of different frequencies of EA in the treatment of CIPN. The results help to prove whether EA is an effective therapy for CIPN and optimize the frequency of EA for CIPN. The results of this study are shared with health care professionals, the public, and relevant organizations through the publication of manuscripts and conference reports.
ChiCTR2100054458.
化疗引起的周围神经病变（CIPN）是癌症患者化疗期间常见的并发症。它主要导致手脚严重麻木，给患者带来极大痛苦。电针被认为有助于改善周围神经病变并缓解手脚麻木。本试验旨在评估不同频率电针对癌症患者CIPN的治疗效果。
本研究为随机对照试验。总共160例符合条件的CIPN患者按1:1:1:1的比例随机分配至2Hz电针组、100Hz电针组、2/100Hz电针组和对照组。电针治疗组的所有患者每周接受3次电针治疗，共4周，并随访4周。对照组患者口服甲钴胺片，一次1片，一日3次，共4周，并随访4周。主要结局指标为参与者神经毒性问卷（PNQ）和周围神经毒性评估分级（NCI CTCAE V5.0）。次要结局指标为生活质量量表（EORTC QLQ-C30）和周围神经传导速度（NCV）测量。在基线、治疗后阶段及随访4周时对结果进行评估。所有主要分析均基于意向性分析原则。
伦理/传播：本方案于2021年12月7日获得中国科学院大学附属肿瘤医院（浙江省肿瘤医院）医学伦理委员会批准。批准文号为IRB-2021-458。本研究提供了不同频率电针治疗CIPN的临床疗效数据。结果有助于证明电针是否为治疗CIPN的有效疗法，并优化CIPN的电针频率。本研究结果将通过发表论文和会议报告与医疗保健专业人员、公众及相关组织分享。
ChiCTR2100054458。
