Breast Cancer Research Center, Motamed Cancer Institute, ACECR, Tehran, Iran.
Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran Medical Sciences, Islamic Azad University, Tehran, Iran.
Trials. 2021 Nov 24;22(1):835. doi: 10.1186/s13063-021-05800-w.
Chemotherapy-induced peripheral neuropathy (CIPN) is a common adverse effect of some chemotherapy regimens. Lithium has been suggested for CIPN in some animal studies. We aimed to study lithium's preventive effect on CIPN in breast cancer patients treated with taxanes and platinum-based medications.
A double-blind placebo-controlled randomized clinical trial (RCT) was implemented on 36 breast cancer patients in two equal-size groups by block randomization. Participants in both groups consumed daily tablets, either placebo or lithium (300 mg), for 5 days in each course of chemotherapy. The tablets were prescribed 1 day before the start of chemotherapy. The electromyography (EMG) and nerve-conduction-velocity (NCV) tests were achieved before the first chemotherapy, 3 and 9 months after the treatment. The changes and signs or symptoms of CIPN, such as numbness, tingling, freezing, sensitivity to touch, muscle weakness, fibrillation, and knee and elbow reflex disorders, were recorded by examination. The trend of outcome changes was compared between two groups during the 9 months of study.
In both groups, neurologic signs and symptoms were exacerbated during the first 3 months and improved up to the ninth month of study. Results showed significant changes of all EMG-NCV variables during the 9 months of research in each group (P < 0.001), but the interaction of time and group effect was not significant in none of those indices. All symptoms changed significantly over the study time (P < 0.001) without significant statistical difference between the two groups (P=0.352). No side effect was found during the study.
The study showed that 300 mg lithium prescription once daily for 5 days might not effectively prevent CIPN in breast cancer patients. Evaluation of lithium effect on CIPN on different cancers in future studies is suggested.
Iranian Registry of Clinical Trials IRCT20160813029327N10 . Registration date: May 16, 2018.
化疗引起的周围神经病（CIPN）是一些化疗方案的常见不良反应。一些动物研究表明锂对 CIPN 有作用。我们旨在研究锂对接受紫杉烷和铂类药物化疗的乳腺癌患者 CIPN 的预防作用。
通过区组随机化，将 36 例乳腺癌患者分为两组，每组 18 例。两组患者均在化疗期间每天服用片剂，一组为安慰剂，另一组为锂（300mg），每个疗程服用 5 天。片剂在化疗开始前 1 天开处方。在第一次化疗前、治疗后 3 个月和 9 个月进行肌电图（EMG）和神经传导速度（NCV）检查。记录 CIPN 的变化和症状或体征，如麻木、刺痛、发冷、触觉敏感、肌肉无力、震颤、膝肘反射障碍等。在 9 个月的研究期间，比较两组之间的结果变化趋势。
两组患者在治疗的前 3 个月神经症状和体征加重，在第 9 个月研究时改善。结果显示，在每组的 9 个月研究中，所有 EMG-NCV 变量均有显著变化（P<0.001），但在这些指标中，时间与组间效应的交互作用均无统计学意义。所有症状在研究期间均有显著变化（P<0.001），两组间无统计学差异（P=0.352）。研究期间未发现不良反应。
本研究表明，每天服用 300mg 锂 5 天可能不能有效预防乳腺癌患者的 CIPN。建议在未来的研究中评估锂对不同癌症 CIPN 的作用。
伊朗临床试验注册中心 IRCT20160813029327N10 。注册日期：2018 年 5 月 16 日。
