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. Issue 7 (23rd February 2018) - Hamstra, Daniel A.
Abstract: 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 (100 mg/kg p.o. b.i.d.) testing the rate of severe (grades 3‐4) mucositis. Results: Sixty patients were randomized. Grade 2 + oral pain was higher with placebo (79% vs 45%; P = .0165), whereas grade 2 + body 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.