Double-Blind, Placebo-Controlled, Randomized Phase II Study of TJ-14 (Hangeshashinto) for Infusional Fluorinated-Pyrimidine-based Colorectal Cancer Chemotherapy-induced Oral Mucositis

Chu Matsuda; Toru Kono; Yoshinori Munemoto; Naoki Nagata; Masato Kataoka; Mitsuru Oshiro; Satoshi Morita; Junichi Sakamoto; Hideyuki Mishima

doi:10.4993/acrt.21.26

Ongoing Clinical Trials

Double-Blind, Placebo-Controlled, Randomized Phase II Study of TJ-14 (Hangeshashinto) for Infusional Fluorinated-Pyrimidine-based Colorectal Cancer Chemotherapy-induced Oral Mucositis

Chu Matsuda, Toru Kono, Yoshinori Munemoto, Naoki Nagata, Masato Kataoka, Mitsuru Oshiro, Satoshi Morita, Junichi Sakamoto, Hideyuki Mishima

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Keywords: colorectal cancer, TJ-14 (Hangeshashinto), herbal medicine (Kampo), mucositis

JOURNAL FREE ACCESS

2013 Volume 21 Issue 1 Pages 26-30

DOI https://doi.org/10.4993/acrt.21.26

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Abstract

In the present study, the efficacy of TJ-14 for the prevention and/or treatment of chemotherapy induced oral mucositis is investigated in a randomized double-blind, placebo-controlled experimental clinical trial in colorectal cancer patients. The primary endpoint of this study is the incidence of persisting≧grade 2 oral mucositis, which is compared between the TJ-14 and placebo groups. The secondary endpoints include the duration of grade≧2 oral mucositis, and the worst oral mucositis grade throughout the protocol therapy, and time to disappearance of oral mucositis. Ninety patients are reqired in the study.

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