{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,23]],"date-time":"2026-07-23T21:52:37Z","timestamp":1784843557938,"version":"3.55.0"},"reference-count":44,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2018,2,23]],"date-time":"2018-02-23T00:00:00Z","timestamp":1519344000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"name":"Molecular Therapeutics Inc"},{"name":"Nizam's Institute of Medical Sciences"},{"name":"Indo-American Cancer Institute and Research Center"},{"name":"Curie Center of Oncology"},{"name":"St. John's Medical College"},{"name":"Karnatak Cancer Therapy and Research Institute"},{"name":"Molecular Therapeutics Inc."}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Head &amp; Neck"],"published-print":{"date-parts":[[2018,7]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>The purpose of this study was to test if oral D\u2010methionine (D\u2010met) reduced mucositis during chemoradiotherapy.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>We conducted a placebo\u2010controlled double\u2010blind randomized phase II trial of D\u2010met (100\u2009mg\/kg p.o. b.i.d.) testing the rate of severe (grades 3\u20104) mucositis.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Sixty patients were randomized. Grade 2\u2009+\u2009oral pain was higher with placebo (79% vs 45%; <jats:italic>P<\/jats:italic>\u2009=\u2009.0165), whereas grade 2\u2009+\u2009body odor was greater with D\u2010met (3% vs 41%; <jats:italic>P<\/jats:italic>\u2009=\u2009.0015). Mucositis was decreased with D\u2010met by the physician (World Health Organization [WHO], <jats:italic>P<\/jats:italic>\u2009=\u2009.007; Radiation Therapy Oncology Group [RTOG], <jats:italic>P<\/jats:italic>\u2009=\u2009.009) and patient functional scales (RTOG, <jats:italic>P<\/jats:italic>\u2009=\u2009.0023). The primary end point of grades 3 to 4 mucositis on the composite scale demonstrated a decrease with D\u2010met (48% vs 24%; <jats:italic>P<\/jats:italic>\u2009=\u2009.058), which was borderline in significance. A planned secondary analysis of a semiquantitative scoring system noted decreased oral ulceration (2.2 vs 1.5; <jats:italic>P<\/jats:italic>\u2009=\u2009.023) and erythema (1.6 vs 1.1; <jats:italic>P<\/jats:italic>\u2009=\u2009.048) with D\u2010met.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Although not meeting the primary end point, results of multiple assessments suggest that D\u2010met decreased mucositis.<\/jats:p><\/jats:sec>","DOI":"10.1002\/hed.25115","type":"journal-article","created":{"date-parts":[[2018,2,23]],"date-time":"2018-02-23T06:34:16Z","timestamp":1519367656000},"page":"1375-1388","source":"Crossref","is-referenced-by-count":23,"title":["Double\u2010blind placebo\u2010controlled multicenter phase II trial to evaluate D\u2010methionine in preventing\/reducing oral mucositis induced by radiation and chemotherapy for head and neck cancer"],"prefix":"10.1002","volume":"40","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6291-3444","authenticated-orcid":false,"given":"Daniel A.","family":"Hamstra","sequence":"first","affiliation":[{"name":"Department of Radiation Oncology Beaumont Health Dearborn Michigan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kuei C.","family":"Lee","sequence":"additional","affiliation":[{"name":"Department of Radiation Oncology Beaumont Health Dearborn Michigan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Avraham","family":"Eisbruch","sequence":"additional","affiliation":[{"name":"Department of Radiation Oncology The University of Michigan Ann Arbor Michigan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Prasad","family":"Sunkara","sequence":"additional","affiliation":[{"name":"Molecular Therapeutics Inc Ann Arbor Michigan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sudhir","family":"Borgonha","sequence":"additional","affiliation":[{"name":"Clinical Evaluation and Testing Services Bangalore India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Babu","family":"Phillip","sequence":"additional","affiliation":[{"name":"St. John's Medical College Bangalore India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kathleen C. 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