Meta-analysis of Patient-level Data on Therapeutic Effects of TJ-14 (Hangeshashinto) for Gastroenterological Cancer Chemotherapy-induced Severe Oral Mucositis with the HANGESHA-G and HANGESHA-Cs : protocol paper

• Published in: Annals of Cancer Research and Therapy Vol. 25; no. 2; pp. 92 - 94
• Main Authors: Aoyama, Toru, Nishikawa, Kazuhiro, Oba, Mari, Yoshikawa, Takaki, Matsuda, Chu, Munemoto, Yoshinori, Takiguchi, Nobuhiro, Tanabe, Kazuaki, Nagata, Naoki, Imano, Motohiro, Oshiro, Mitsuru, Fukushima, Ryoji, Kataoka, Masato, Morita, Satoshi, Tsuburaya, Akira, Mishima, Hideyuki, Kono, Toru, Sakamoto, Junichi
• Format: Journal Article
• Language: English
• Published: Tokyo The Japanese Society of Strategies for Cancer Research and Therapy 2017; Japan Science and Technology Agency
• Subjects: Cancer; Chemotherapy; chemotherapy-induced oral mucositis (COM); Clinical trials; Data processing; Gastroenterological cancer; Hangeshashinto (TJ-14); Meta-analysis; Mucositis; Patients; Remission
• ISSN: 1344-6835; 1880-5469
• DOI: 10.4993/acrt.25.92

This meta-analysis will be performed to evaluate the efficacy of Hangeshashinto (TJ-14) in patients with chemotherapy-induced oral mucositis (COM) for gastroenterological cancer. Individual patient–level data from two prospective, double-blind, placebo-controlled randomized trials employing the same regimens using TJ-14 will be collected for this study. Cumulative data from 181 patients will help conclude whether TJ-14 is effective to COM for gastroenterological cancer or not. We will select the patients with severe (CTCAE grade ≥2) COM who did not reduce the dose of chemotherapy to evaluate the effect of TJ-14 precisely. The primary endpoint of this study is time to remission of severe (CTCAE grade ≥2) COM to grade ≤1 in the protocol treatment course, and the secondary end points are the incidence of grade ≥2 COM, and predictive factors of time to remission and of incidence of grade ≥2 COM.