Double-blind placebo-controlled multicenter phase II trial to evaluate D-methionine in preventing/reducing oral mucositis induced by radiation and chemotherapy for head and neck cancer.

Background: The purpose of this study was to test if oral D-methionine (D-met) reduced mucositis during chemoradiotherapy. Methods: We conducted a placebo-controlled double-blind randomized phase II trial of D-met (100mg/kg p. o. b. i. d.) testing the rate of severe (grades 3-4) mucositis. Results: Sixty patients were randomized. Grade 21oral pain was higher with placebo (79% vs 45%; P=.0165), whereas grade 21body odor was greater with D-met (3% vs 41%; P=.0015). Mucositis was decreased with D-met by the physician (World Health Organization [WHO], P=.007; Radiation Therapy Oncology Group [RTOG], P=.009) and patient functional scales (RTOG, P=.0023). The primary end point of grades 3 to 4 mucositis on the composite scale demonstrated a decrease with D-met (48% vs 24%; P=.058), which was borderline in significance. A planned secondary analysis of a semiquantitative scoring system noted decreased oral ulceration (2.2 vs 1.5; P=.023) and erythema (1.6 vs 1.1; P=.048) with D-met. Conclusion: Although not meeting the primary end point, results of multiple assessments suggest that D-met decreased mucositis.