Objective. To evaluate the efficacy of Goshajinkigan for oxaliplatin-induced peripheral neuropathy in colorectal cancer patients. Patients. Colorectal cancer patients ( ) who received ≥4 weeks of Goshajinkigan for oxaliplatin-induced peripheral neuropathy during chemotherapy at Kyoto Prefectural University of Medicine were (Goshajinkigan group) compared to 44 patients who had not received Goshajinkigan during the same period (non-Goshajinkigan group). Main Outcome Measures. The effect of Goshajinkigan was graded as curative, effective, stabilizing, or deleterious. The relationships between the grade of peripheral neuropathy and the dose of oxaliplatin in the Goshajinkigan and non-Goshajinkigan groups were evaluated. Results. The effect of Goshajinkigan on peripheral neuropathy in the Goshajinkigan group was curative, effective, stabilizing, and deleterious in 3.4, 20.7, 69.0, and 6.9% of patients, compared to the effect in the non-Goshajinkigan group (4.5, 15.9, 45.5, and 34.1%). The ratio of deleterious effects was significantly different between these two groups ( ). A Kaplan-Meier analysis in relation to the cumulative dose of oxaliplatin showed that the incidence of grade 3 peripheral neuropathy tended to be less in the Goshajinkigan group ( ). There were no significant differences in time to treatment failure and severe adverse events between these two groups. Conclusions. Goshajinkigan prevented exacerbation of oxaliplatin-induced peripheral neuropathy. This trial is registered with UMIN000009956 1. Introduction Oxaliplatin-based chemotherapy regimens such as XELOX (CapeOX) and FOLFOX have gained acceptance worldwide as first-line therapies in advanced or recurrent colorectal cancer; subsequently, the incidence of the often intractable oxaliplatin-induced peripheral neuropathy also continues to rapidly increase [1]. Peripheral neuropathy occurs in approximately 80% of the patients receiving oxaliplatin-based chemotherapy. Grade 3 peripheral neuropathy affects approximately 15% of the patients after a cumulative dose of 800？mg/m2 and requires discontinuation of therapy [2]. The unique direct effect of oxaliplatin on nerve excitability has been attributed to one of its metabolites, oxalate, which is a calcium chelator that alters voltage-gated Na+ channels. In experimental models, acute dysfunction of Na+ channels is correlated with axonal loss and degeneration [3]. Furthermore, cumulative neurotoxicity may be related to direct toxicity of the dorsal root ganglia [4]. The hallmarks of oxaliplatin-induced peripheral neuropathy are paresthesia and
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