Daniel A Hamstra1, Kuei C Lee1, Avraham Eisbruch2, Prasad Sunkara3, Sudhir Borgonha4, Babu Phillip5, Kathleen C M Campbell6, Brian D Ross7,8,3, Alnawaz Rehemtulla2,3. 1. Department of Radiation Oncology, Beaumont Health, Dearborn, Michigan. 2. Department of Radiation Oncology, The University of Michigan, Ann Arbor, Michigan. 3. Molecular Therapeutics Inc, Ann Arbor, Michigan. 4. Clinical Evaluation and Testing Services, Bangalore, India. 5. St. John's Medical College, Bangalore, India. 6. Department of Medical Microbiology, Immunology, and Cell Biology, Southern Illinois University School of Medicine, Springfield, Illinois. 7. Department of Radiology, The University of Michigan, Ann Arbor, Michigan. 8. Department of Biological Chemistry, The University of Michigan, Ann Arbor, Michigan.
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.
RCT Entities:
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-metdecreased mucositis.