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

Abstract

BackgroundThe purpose of this study was to test if oral D‐methionine (D‐met) reduced mucositis during chemoradiotherapy.MethodsWe 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.ResultsSixty 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.ConclusionAlthough not meeting the primary end point, results of multiple assessments suggest that D‐met decreased mucositis.