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

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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.