A traditional Japanese medicine-Hangeshashinto (TJ-14)-alleviates chemoradiation-induced mucositis and improves rates of treatment completion

Oral mucositis induced by radiation or chemoradiation can cause devastating quality of life issues for patients undergoing treatment for head and neck cancer. In this study, we investigated the efficacy of a traditional Japanese medicine-Hangeshashinto (TJ-14)-for (chemo)radiation-induced oral mucositis. Eighty patients who underwent whole neck radiation of > 60 Gy with or without chemotherapy (high-dose cisplatin or low-dose docetaxel) were enrolled in this retrospective study; 40 had received TJ-14 during treatment, and 40 had not (controls). Factors related to alleviation of oral mucositis were identified by multivariate logistic regression analysis. Rates of completion of (chemo)radiation treatments were compared between the patients who received TJ-14 and the control group according to the treatment regimen. The comparison of the nutrition status between groups was also performed. Multivariate analysis indicated that the use of TJ-14 (p = 0.019), gender (p = 0.024), and primary tumor location (p = 0.028) were significant factors associated with the severity of oral mucositis. TJ-14 was associated with a significantly improved rate of completion of chemoradiation with cisplatin (p = 0.002). In the investigation of nutritional status, only serum albumin was significantly maintained better in the TJ-14 group than the control group in terms of mean change before and after (chemo)radiation (p = 0.024). The present study indicates that TJ-14 is effective for ameliorating oral mucositis induced by (chemo)radiation in patients with head and neck cancers. TJ-14 was associated with improved completion rates of chemoradiation treatments with cisplatin. A randomized controlled trial is necessary to confirm the efficacy of TJ-14 for chemoradiation-induced mucositis in head and neck cancer patients.