Effectiveness of Hangeshashinto in delaying grade 2 radiotherapy-induced mucositis development in patients with hypopharyngeal or laryngeal cancer: Preliminary finding of a randomized clinical trial.

BACKGROUND: The efficacy of Hangeshashinto (TJ-14) during radiotherapy administration in patients with head and neck cancer remains unknown. We investigated the effectiveness of TJ-14 in delaying grade 2 radiotherapy-induced mucositis development in patients with hypopharyngeal or laryngeal cancer. METHODS: The trial involved 28 participants, allocated in a 1:1 ratio, to either the control or intervention group using a stratified randomization method adjusted for primary cancer location and treatment type. RESULTS: Kaplan-Meier curves showed that the 50% incidence rate of grade 2 pharyngeal mucositis between the intervention and control group (46 Gy vs 34 Gy, P = .49). Six participants in the intervention group stopped taking TJ-14 during the development of grade 1 pharyngeal mucositis (mean oral medication period: 2.7 days). CONCLUSION: The findings of this single-center randomized clinical trial showed that taking TJ-14 from the onset of grade 1 mucositis tended to delay the development of grade 2 mucositis. However, patient compliance was poor in the intervention group. Therefore, multicenter randomized controlled trials should be planned with considering the low compliance of this population to understand the effectiveness of TJ-14.