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

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.

• Authors: Daniel A Hamstra, Kuei C Lee, Avraham Eisbruch, Prasad Sunkara, Sudhir Borgonha, Babu Phillip, Kathleen C M Campbell, Brian D Ross, Alnawaz Rehemtulla
• Journal: Head & neck (Head Neck) Vol. 40 Issue 7 Pg. 1375-1388 (07 2018) ISSN: 1097-0347 [Electronic] United States
• PMID: 29473247 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © 2018 Wiley Periodicals, Inc.

Chemical References

• Antineoplastic Agents
• Methionine
• Cisplatin

Topics

• Administration, Oral
• Antineoplastic Agents (administration & dosage, adverse effects)
• Carcinoma, Squamous Cell (therapy)
• Chemotherapy, Adjuvant (adverse effects)
• Cisplatin (administration & dosage, adverse effects)
• Double-Blind Method
• Female
• Head and Neck Neoplasms (therapy)
• Humans
• Male
• Methionine (therapeutic use)
• Middle Aged
• Radiotherapy, Adjuvant (adverse effects)
• Stomatitis (classification, etiology, prevention & control)