Prevention of the Chemotherapy-Induced Oral Mucositis in Esophageal Cancer by Use of Hangeshashinto (TJ-14)

Abstract

Objective: Oral mucositis and diarrhea are adverse effects (AEs) of chemotherapy and chemoradiotherapy (CR/CRT) that commonly occur in patients of esophageal cancer (EC). We investigated whether Hangeshashinto (TJ-14)—a Japanese traditional medicine—could control oral mucositis, pain, incidence of esophagitis, and diarrhea in patients who underwent CT/CRT for EC. Methods: We enrolled 39 patients (36 men, 3 women) who underwent docetaxel- or cisplatin-based CT/CRT for EC between July 2012 and June 2014, of whom 19 used TJ-14 dissolved in water as an oral rinse 3 times a day over the first 2 courses of their treatment, and 20 (the control group) received no particular prophylaxis against mucositis. Their AEs, including mucositis, were evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Results: Although incidences of oral mucositis, appetite loss, nausea, constipation, and vomiting did not significantly differ between the TJ-14 group and controls, diarrhea incidence was significantly lower in the TJ-14 group by the second treatment course (P = 0.0261 by per protocol set analyses). Conclusions: TJ-14 significantly decreases diarrhea caused by CT/CRT in patients treated for EC, although TJ-14 cannot prevent of causing oral mucositis.