Prophylaxis of Oral Mucositis with Iodine Solution during Concurrent Chemoradiation of Head and Neck Cancer: Preliminary Results of a Double-Blind, Randomized Controlled Trial

OBJECTIVE: This study aims to evaluate the clinical efficacy of an in-house iodine solution (IS) mouthwash for the prophylaxis of concurrent chemoradiation (CCRT) induced oral mucositis (OM) in head & neck cancer (HNC) patients. METHODS: This prospective, double-blind, randomized controlled trial was conducted on 20 HNC patients, being treated with definite or postoperative CCRT, at the Division of Radiation Oncology, Department of Radiology, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand. The patients were randomly assigned (1:1) to the treatment group or the control group. Patients in the treatment group gargled IS three times daily after meals, while patients in the control group gargled normal saline solutions (NSS). Assessment of OM was performed before starting CCRT, once a week during CCRT, and 4 weeks after CCRT was completed. The primary outcome was Oral Mucositis Assessment Scale (OMAS). RESULTS: The mean weekly OMAS, pain score, and impact on swallowing score were not statistically significant in patients who rinsed with IS mouthwash compared to those who received NSS (p > 0.999 in every week). There was no difference in the mean onset to OM (all grades) (p = 0.704), and the mean duration of OM (all grades) (p = 0.365). Severe OM (WHO grade 3-4) occurred in three patients [IS=2, NSS=1] with the median onset of 45.50 and 33.00 days (p = NA), and the duration of 8.00 and 57.00 days (p = NA) in the IS and NSS groups, respectively. Oral candidiasis occurred in one patient from the NSS group while no secondary infection of oral mucosa was observed in the patients receiving IS mouthwash. CONCLUSION: The study could not reach statistically significance to show that IS mouthwash was effective in of prevention CCRT-induced OM. Further study with a larger number of participants is encouraged.