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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
Intervention Characteristics/Basic Study Process
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.
Sample Characteristics
N = 90
MEDIAN AGE = 67 years (range = 49–84 years)
MALES: 55.5%, FEMALES: 44.5%
KEY DISEASE CHARACTERISTICS: Chemotherapy-induced oral mucositis in patients with colorectal cancer
OTHER KEY SAMPLE CHARACTERISTICS: Fluorinated pyrimidine-based chemotherapy
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.
Conclusions
This study did not meet its primary endpoint. TJ-14 demonstrated a potential treatment effect on mucositis ≥ grade 2 .
Limitations
Small sample (< 100)
Nursing Implications
TJ-14 is a Japanese traditional herbal medicine consisting of a mixture of seven herbs. Additional study is needed to fully evaluate its effectiveness.