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
; 40(7): 1375-1388, 2018 07.
Article
em En
| MEDLINE
| ID: mdl-29473247
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.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Estomatite
/
Quimioterapia Adjuvante
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Radioterapia Adjuvante
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Neoplasias de Cabeça e Pescoço
/
Metionina
Tipo de estudo:
Clinical_trials
/
Etiology_studies
Limite:
Female
/
Humans
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Male
/
Middle aged
Idioma:
En
Revista:
Head Neck
Assunto da revista:
NEOPLASIAS
Ano de publicação:
2018
Tipo de documento:
Article