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.

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.

Head Neck. 2018 Feb 23;:

Authors: Hamstra DA, Lee KC, Eisbruch A, Sunkara P, Borgonha S, Phillip B, Campbell KCM, Ross BD, Rehemtulla 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.

PMID: 29473247 [PubMed - as supplied by publisher]

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