Annals of Cancer Research and Therapy
Online ISSN : 1880-5469
Print ISSN : 1344-6835
ISSN-L : 1344-6835
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
Toru AoyamaKazuhiro NishikawaMari ObaTakaki YoshikawaChu MatsudaYoshinori MunemotoNobuhiro TakiguchiKazuaki TanabeNaoki NagataMotohiro ImanoMitsuru OshiroRyoji FukushimaMasato KataokaSatoshi MoritaAkira TsuburayaHideyuki MishimaToru KonoJunichi Sakamoto
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2017 Volume 25 Issue 2 Pages 92-94

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Abstract

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.

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© 2017 by The Japanese Society of Strategies for Cancer Research and Therapy
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