Magic Mouthwash + Sucralfate Nonsuperior to Benzydamine for Prophylaxis of Radiation-Induced Oral Mucositis in Head and Neck Cancer

CHICAGOThe combination of magic mouthwash and sucralfate was not superior to single-agent benzydamine hydrochloride for the prophylactic treatment of radiation-induced oral mucositis, Joda S. Kuk, MD, of the Juravinski Cancer Centre, Hamilton, ON, Canada, and colleagues reported at the American Society of Clinical Oncology's 2011 Annual Meeting.

The primary endpoint in this Phase 3, randomized, multicenter trial, was mean change in the Oral Mucositis Weekly Questionnaire—Head and Neck (OMWQ-HN) score from baseline to 6 weeks.

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 (diphenhydramine, dexamethasone, and nystatin) followed by sucralfate (MM+S) or 0.15% benzydamine hydrochloride. Mouthwash regimens were used four 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.

Of the 67 patients enrolled in the trial, 32 were randomized to receive MM+S and 35 to receive benzydamine hydrochloride. 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% CI, -13.4–2.4]; P=0.16). The number of WHO Grade 3 or 4 events of oral mucositis after 4 weeks of RT was 22.6% with MM+S and 5.9% with benzydamine (P=0.07). Time to opioid initiation or increase was not statistically different between the two arms (17 events with MM+S vs. nine events with benzydamine; HR=2.2; [0.96–4.84]; P=0.06).

Dr. Kuk et al concluded that magic mouthwash and sucralfate was no more effective than single-agent benzydamine hydrochloride for the prophylactic treatment of radiation-induced oral mucositis. He noted that his institution uses magic mouthwash because “patients love it” and report relief within the first three days. Plus it is inexpensive. At six weeks, however, the majority of patients have oral mucositis regardless of the agent used. For that reason, different treatment strategies should continue to be explored, Dr. Kuk said. Currently, palifermin is available to treat oral mucositis in patients with hematologic malignancies who receive high doses of chemotherapy and radiation therapy prior to bone marrow transplantation. Dr. Kuk is a 2011 Merit Award Recipient.