A randomized phase III trial of magic mouthwash and sucralfate versus benzydamine hydrochloride for prophylaxis of radiation-induced oral mucositis in head and neck cancer.

5521 Background: This study evaluated the relative efficacy of magic mouthwash (diphenhydramine, dexamethasone and nystatin) plus sucralfate compared to benzydamine hydrochloride in reducing the severity of patient-reported symptoms of mucositis. METHODS Patients receiving primary or post-operative radiotherapy (RT) for squamous cell carcinoma of the head and neck were stratified according to the use of concurrent cisplatin chemotherapy, and then randomized to receive either magic mouthwash followed by sucralfate (MM+S) or 0.15% benzydamine hydrochloride. Mouthwash regimens were used 4 times daily, from day 1 of RT until 2 weeks post-completion of RT. The prescribed RT dose was 60-70Gy delivered over 6-7 weeks. The primary endpoint was mean change in the Oral Mucositis Weekly Questionnaire - Head and Neck (OMWQ-HN) score from baseline to 6 weeks. RESULTS Sixty-seven patients were enrolled between May 2009 - May 2010, and randomly assigned to receive MM+S (n=32) or benzydamine (n=35). There were no statistically significant differences in outcomes between the two treatment arms. The mean change in OMWQ-HN score was 15.7 [standard deviation (SD) = 17.5] with MM+S, and 21.2 (SD = 13.8) with benzydamine [absolute difference of -5.5; 95% Confidence Interval (CI), -13.4 to 2.4; P = .16]. The incidence of WHO grade 3 or 4 oral mucositis after 4 weeks of RT was 3.2% with MM+S and 17.6% with benzydamine (P = .11). Time to opioid initiation or increase was not statistically different between the two arms (17 events with MM+S vs. 9 events with benzydamine; hazard ratio 2.2; 95% CI, 0.96 to 4.84; P = .06). CONCLUSIONS The combination of magic mouthwash and sucralfate was not superior to single-agent benzydamine hydrochloride for the prophylactic treatment of radiation-induced oral mucositis.