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

• Published in: Head & neck 2018-07, Vol.40 (7), p.1375-1388
• Main Authors: Hamstra, Daniel A., Lee, Kuei C., Eisbruch, Avraham, Sunkara, Prasad, Borgonha, Sudhir, Phillip, Babu, Campbell, Kathleen C. M., Ross, Brian D., Rehemtulla, Alnawaz
• Format: Article
• Language: English
• Subjects: Cancer; Chemoradiotherapy; Chemotherapy; clinical trial; Double-blind studies; Erythema; Head & neck cancer; Methionine; Mucositis; Odor; Pain; Radiation therapy; radioprotector; radiotherapy; toxicity
• ISSN: 1043-3074; 1097-0347
• DOI: 10.1002/hed.25115

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.