Topical Application of Hangeshashinto (TJ-14) in the Treatment of Chemotherapy-Induced Oral Mucositis

Background The optimal treatment of chemotherapy-induced oral mucositis is not well established. A recent study showed that hangeshashinto (TJ-14) might be useful for periodontal disease via downregulating pro-inflammatory prostaglandins in the cyclooxygenase pathway in human. Our study aimed to determine whether TJ-14 is effective in the management of chemotherapy-induced oral mucositis. Methods Fourteen patients afflicted with chemotherapy-induced oral mucositis during mFOLFOX6 or FOLFIRI treatment for metastasis of advanced colorectal cancer were randomly assigned to topical TJ-14 treatment thrice daily for 7 days. Patients prepared a 50 ml solution with 2.5 g of TJ-14 dissolved in tap water and rinsed their oral mucosa for more than 5 seconds and then expectorated it. TJ-14 was also topically applied with a cotton pellet on the mucosal lesions. The severity of oral mucositis was evaluated using the Common Terminology Criteria for Adverse Events version 4 before and after one-week TJ-14 treatment. Results After the one-week topical treatment with TJ-14, thirteen of the fourteen patients (92.8 %) showed improvements in oral mucositis, with significantly decreased mean CTCAE grades (P = 0.0012). Compared to baseline, none of the patients' CTCAE grades worsened. The compliance of TJ-14-treatment was good and side effects from TJ-14 were not observed. Conclusions Topical application of TJ-14 may have therapeutic effects in patients with chemotherapy-induced oral mucositis via downregulation of pro-inflammatory prostaglandins. A prospective, randomized, controlled, double-blind studies are necessary to confirm the findings of this open-label, pilot study.