Topical application of hangeshashinto (TJ-14) in the management of chemotherapy-induced oral mucositis: A preliminary study.

603 Background: Oral mucositis is a common toxicity associated with cytotoxic chemotherapy used for cancer treatment and results in severe discomfort and impairs patients' ability to eat, swallow, and talk. The treatment of chemotherapy-induced oral mucositis is not well established. The cyclooxygenase pathway mediates tissue injury and pain through upregulation of pro-inflammatory prostaglandins. Recent study showed that one of the Japanese traditional medicines (kampo), hangeshashinto (TI-14), may be useful for periodontal disease via downregulation of pro-inflammatory prostaglandins in human. The aim of this study was to evaluate the effect of TJ-14 on chemotherapy- induced oral mucositis. Methods: Fourteen patients with chemotherapy-induced oral mucositis during mFOLFOX6 or FOLFIRI treatment for requiring to the metastasis of advanced colorectal cancer were received topical application of TJ-14. Topical TJ-14 was applied to the oral mucositis three times a day. Patients were asked to make 50 mL of TJ-14 solution (2.5 g) with a tap water and were advised to rinse the TJ-14 solution on the oral mucosa for 10 seconds and then to spill it. Additionally, TJ-14 was topically applied with a cotton pellet on the oral mucositis. The above treatment was advised throughout the course of chemotherapy. Patients were evaluated for the oral mucositis using the Common Terminology Criteria for Adverse Events (CTCAE) version 4 before and after 2-weeks TJ-14 treatment. Results: Thirteen of the fourteen patients (92.8 %) responded to the TJ-14 therapy. There was significant reduction in the grade 3/4 mucositis from 3.2 to 1.8 (p=0.02) as well as in the grade 1/2 mucositis from 1.6 to 0.6 (p=0.034). There is no patient showed worse than before. The compliance of TJ-14-treatment was good. Conclusions: Topical application of TJ-14 may have therapeutic effects on chemotherapy-induced oral mucositis via downregulation of pro-inflammatory prostaglandins. No significant financial relationships to disclose.