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

Abstract

This meta-analysis will be performed to evaluate the efficacy of Hangeshashinto (TJ-14) in patients with chemotherapyinduced oral mucositis (COM) for gastroenterological cancer. Individual patient-level data from two prospective, doubleblind, 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.