Matsuda, C., Munemoto, Y., Mishima, H., Nagata, N., Oshiro, M., Kataoka, M., . . . Kono, T. (2015). Double-blind, placebo-controlled, randomized phase II study of TJ-14 (Hangeshashinto) for infusional fluorinated-pyrimidine-based colorectal cancer chemotherapy-induced oral mucositis. Cancer Chemotherapy and Pharmacology, 76, 97–103.
To determine if TJ-1 (hangeshanshinto), a Japanese traditional herbal medicine, prevents and controls chemotherapy-induced oral mucositis
Patients who developed greater than World Health Organization (WHO) grade 1 oral mucositis during the first screening cycle of chemotherapy were eligible for a central 1:1 randomization to the study or control group. Three times each day, patients dissolved 2.5 g of TJ-14 or a placebo in 50 ml of water and rinsed the oral cavity. Patients were trained in the clinic. Treatment started on the first day of chemotherapy and continued for 14 days. Assessments using the WHO oral mucositis scale were done three times per week on nonconsecutive days during the screening cycle and treatment cycles 1 and 2. Assessments continued for three weeks or until mucositis returned to grade 0. Safety and adverse events were assessed.
Multi-institutional, double-blinded, placebo-controlled, randomized, phase 2 trial
There was no significant difference in the incidence and severity of oral mucositis between the groups. The duration of grade ≥ 2 mucositis was 5.5 days in the treatment group and 10.5 days in the placebo group.
This study did not meet its primary endpoint. TJ-14 demonstrated a potential treatment effect on mucositis ≥ grade 2 .
TJ-14 is a Japanese traditional herbal medicine consisting of a mixture of seven herbs. Additional study is needed to fully evaluate its effectiveness.