The Efficacy and Safety of Traditional Chinese Medicine Qufenghuoxue Formula on Peripheral Neuropathy Induced by Paclitaxel in Advanced Lung Cancer：A Randomized Clinical Trial

Abstract Purpose To assess the benefits of hands and feet immersion with traditional Chinese medicine (TCM) Qufenghuoxue formula on chemotherapy-induced peripheral neuropathy (CIPN) in advanced lung cancer patients receiving paclitaxel. Methods In this prospective trial, 227 patients with CIPN grading 2–3 randomly received TCM therapy, oral vitamin B1 or warm water immersion during paclitaxel chemotherapy. Assessment measures such as Neuropathy Pain Scale (NPS), and the potential of completing recommended paclitaxel dosing were used to evaluate the efficacy. Results The incidence of sensory peripheral neuropathy and motor peripheral neuropathy with NCI-CTCAE grading 2–3 dropped to 83.3% and 73.6% in TCM group, significantly lower than vitamin B1 and warm water groups (P < 0.001). TCM therapy improved FACT/GOG-Ntx (11.5 vs 20.4 vs 22.4), NPS (16.8 vs 27.7 vs 29.2) and Quality of Life scales (42.6 vs 36.0 vs 33.6) (all P < 0.001). Compared to vitamin B1 and warm water groups, more patients in TCM group experienced CIPN relief (48.6% vs 12.0% vs 7.5%, P < 0.001) with decreased mean time to CIPN relief. TCM group also had greater potential of completing recommended dose level of paclitaxel (83.8% vs 74.6% vs 59.7%, P = 0.0034). With warm water as a reference, the multivariate hazard ratio of paclitaxel dose reductions/cessation as a result of CIPN was 0.34 for TCM and 0.56 for vitamin B1. Conclusion Qufenghuoxue formula was a feasible strategy in relieving CIPN-related symptoms, reducing CIPN severity grading, and improving the potential of completing recommended paclitaxel dosing in advanced lung cancer patients. Trial Registration Chinese Clinical Trial Registry No. ChiCTR2300069949. Registered 30 March 2023, URL www.chictr.org/cn/.