Efficacy and Safety of Heat-Sensitive Moxibustion Combined with Herbal Fumigation for Oxaliplatin-Induced Peripheral Neuropathy: A Single-Center Randomized Controlled Trial

Abstract Background This study evaluated the clinical efficacy and safety of combining heat-sensitive moxibustion (HSM) with herbal fumigation and washing (HFW) for patients with colorectal cancer (CRC) suffering from oxaliplatin-induced peripheral neuropathy (OIPN), specifically those presenting with the traditional Chinese medicine (TCM) syndrome of qi stagnation and blood stasis. Methods This single-center randomized controlled trial enrolled 70 patients with CRC complicated by OIPN and qi stagnation and blood stasis syndrome who were treated at Nanjing Hospital of Traditional Chinese Medicine from January 9 to June 2026. Participants were randomized 1:1 to a control group or an intervention group, with 35 patients in each group. All participants received standard chemotherapy and routine nursing care. The control group underwent adjunctive HFW, while the intervention group received concurrent HSM in addition to the same HFW. The intervention lasted for two consecutive chemotherapy cycles. The primary outcome was the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy 20 (EORTC QLQ-CIPN20) score. Secondary outcomes included peripheral neuropathy grade according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v5.0), Numerical Rating Scale (NRS) score, TCM syndrome score, and nerve conduction velocity (NCV). The study protocol was approved by the Ethics Committee of Nanjing Hospital of Traditional Chinese Medicine on January 8, 2026 (approval No. 2026KY006-01), before enrollment of the first participant on January 9, 2026. The trial was retrospectively registered with the International Traditional Medicine Clinical Trial Registry (ITMCTR; registration No. ITMCTR2026001917) on May 22, 2026. Results A total of 67 patients were included in the per-protocol analysis, comprising 34 patients in the control group and 33 patients in the intervention group. The estimated cumulative oxaliplatin exposure before enrollment did not differ significantly between groups (p = 0.981). After treatment and at 4 weeks after completion of the intervention, the EORTC QLQ-CIPN20 scores were lower in the intervention group than in the control group, with between-group differences of -2.39 points (95% CI: -3.60 to -1.19; p < 0.001) and − 3.03 points (95% CI: -4.33 to -1.74; p < 0.001), respectively. NCI-CTCAE v5.0 neuropathy grade was also less severe in the intervention group at both time points (p = 0.006 and p = 0.028). After treatment, the TCM syndrome score was lower in the intervention group than in the control group (p < 0.001), and motor nerve conduction velocities of the median nerve and common peroneal nerve were higher (p = 0.016 and p = 0.006). No statistically significant between-group differences were observed in sensory nerve conduction velocities or NRS scores. No serious adverse events occurred in either group. Conclusion The adjunctive application of HSM to HFW effectively reduced the short-term overall symptom burden of OIPN and mitigated the severity of peripheral neuropathy in CRC patients with qi stagnation and blood stasis syndrome, with no serious adverse events observed. The short-term benefits of this multimodal approach primarily translated into a reduction in neurological symptom burden and functional limitations, rather than providing direct analgesia. This accessible regimen holds promise as an adjunctive, non-pharmacological supportive care strategy in oncology, though larger multicenter trials are warranted to establish its long-term efficacy and clinical significance.