Effects of Electroacupuncture and Mecobalamin for Utidelon-Induced Peripheral Neuropathy in Breast Cancer Patients: A Randomized Controlled Clinical Trial
Chao Lü, Qiongying Shen, Dehou Deng, Yajun Zhang, Peipei Wang, Xiying Shao, Yaping Deng, Wenlong Bao, Weiji Chen, Guangliang Li
Abstract
Objective: The chemotherapy agent Utidelone (UTD1), as a novel option for drug-resistant breast cancer patients, is prone to cause severe neurotoxicity. This study aims to evaluate the clinical effects of electroacupuncture (EA) and Mecobalamin (MeCbl) in treating Utidelone-induced peripheral neuropathy (UIPN), providing preliminary evidence to optimize clinical management strategies. Methods: A total of 60 eligible breast cancer patients with UIPN were randomly assigned in a 1:1 ratio to either the EA group or the MeCbl group. Evaluations were conducted after 4 weeks of treatment and again following a 4-week follow-up period (week 8). The primary outcome was the overall response rate of the Patient Neurotoxicity Questionnaire (PNQ), which was defined as a reduction of at least one grade in PNQ sensory or motor symptoms at week 4 compared to baseline. Secondary outcomes included the PNQ sensory, PNQ motor, and NCI-CTCAE grades, the EORTC QLQ-CIPN20 and QLQ-C30 scales. Results: 28 of 30 participants in the EA group and 29 of 30 participants in the MeCbl group completed the study. The responder rate of PNQ overall in the EA group was significantly higher than that in the MeCbl group at week 4 ( P =0.015) and at week 8 ( P =0.01). EA group exhibited significant improvements in PNQ sensory, PNQ motor, and NCI-CTCAE grades compared to baseline at week 4 (all P < 0.05). EA treatment also demonstrated the ability to alleviate UIPN symptoms and improve the quality of life in several aspects, as indicated by the EORTC QLQ-CIPN20 and QLQ-C30 scales. There were no serious treatment-related adverse events in either group. Conclusion: This randomized clinical trial indicated that EA therapy showed a potential benefit to alleviate symptoms of UIPN in breast cancer patients. Nevertheless, further research involving larger sample sizes and extended follow-up periods is warranted to elucidate these effects. Trial registration: No. ChiCTR2200062741. Keywords: electroacupuncture, EA, breast cancer, Utidelon-induced peripheral neuropathy, UIPN, Mecobalamin, MeCbl, randomized controlled trial