title: L-glutamine decreases the severity of mucositis induced by chemoradiotherapy in patients with locally advanced head and neck cancer: a double-blind, randomized, placebo-controlled trial.
abstract: The incidence of severe mucositis in the oral cavity, pharynx and larynx is high among patients with head and neck cancer (HNC) receiving chemoradiotherapy (CRT), resulting in significant pain and impairment of quality of life. The present study investigated whether L-glutamine (glutamine) decreases the severity of mucositis in the oral cavity, pharynx and larynx induced by CRT. This double-blind, randomized, placebo-controlled trial included 40 untreated patients with squamous cell carcinoma of the nasopharynx, oropharynx, hypopharynx or larynx. Patients received 66 or 70 Gy of total radiation at the rate of 2 Gy/fraction daily and 5 fractions/week. Cisplatin (20 mg/m2) and docetaxel (10 mg/m2) were intravenously co-administered once a week for 6 weeks. Patients were randomized to orally receive either glutamine (group G) or placebo (group P) at a dose of 10 g 3 times a day throughout the CRT course. Mucositis was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0. The primary end point was mucositis severity. Mucositis developed in all patients. A maximal mucositis grade of G4 was observed in 0 and 25% group G and P patients, respectively, while that of G2 was observed in 10 and 0% group G and P patients, respectively (p=0.023). Glutamine significantly decreased the maximal mucositis grade (group G, 2.9±0.3; group P, 3.3±0.4; p=0.005) and pain score at weeks 4, 5 and 6. Glutamine significantly decreased mucositis severity in the oral cavity, pharynx and larynx induced by CRT in patients with HNC.
authors.affiliation: Department of Complementary and Alternative Medicine, Osaka University Graduate School of Medicine, Suita, Osaka, Japan.
authors.forename: Takae
authors.initials: T
authors.lastname: Tsujimoto
authors.affiliation: Department of Otorhinolaryngology-Head and Neck Surgery, Osaka University Graduate School of Medicine, Suita, Osaka, Japan.
authors.forename: Yoshifumi
authors.initials: Y
authors.lastname: Yamamoto
authors.affiliation: Department of Pediatric Surgery, Osaka University Graduate School of Medicine, Suita, Osaka, Japan.
authors.forename: Masafumi
authors.initials: M
authors.lastname: Wasa
authors.affiliation: Department of Otorhinolaryngology-Head and Neck Surgery, Osaka University Graduate School of Medicine, Suita, Osaka, Japan.
authors.forename: Yukinori
authors.initials: Y
authors.lastname: Takenaka
authors.affiliation: Department of Otorhinolaryngology-Head and Neck Surgery, Osaka University Graduate School of Medicine, Suita, Osaka, Japan.
authors.forename: Susumu
authors.initials: S
authors.lastname: Nakahara
authors.affiliation: Department of Pharmainformatics and Pharmacometrics, Osaka University Graduate School of Pharmaceutical Sciences, Suita, Osaka, Japan.
authors.forename: Tastuya
authors.initials: T
authors.lastname: Takagi
authors.affiliation: Department of Clinical Pharmacy Research and Education, Osaka University Graduate School of Pharmaceutical Sciences, Suita, Osaka, Japan.
authors.forename: Mamiko
authors.initials: M
authors.lastname: Tsugane
authors.affiliation: Department of Complementary and Alternative Medicine, Osaka University Graduate School of Medicine, Suita, Osaka, Japan.
authors.forename: Noriyuki
authors.initials: N
authors.lastname: Hayashi
authors.affiliation: Department of Complementary and Alternative Medicine, Osaka University Graduate School of Medicine, Suita, Osaka, Japan.
authors.forename: Kazuhisa
authors.initials: K
authors.lastname: Maeda
authors.affiliation: Department of Otorhinolaryngology-Head and Neck Surgery, Osaka University Graduate School of Medicine, Suita, Osaka, Japan.
authors.forename: Hidenori
authors.initials: H
authors.lastname: Inohara
authors.affiliation: Department of Clinical Pharmacy Research and Education, Osaka University Graduate School of Pharmaceutical Sciences, Suita, Osaka, Japan.
authors.forename: Etsuko
authors.initials: E
authors.lastname: Uejima
authors.affiliation: Department of Complementary and Alternative Medicine, Osaka University Graduate School of Medicine, Suita, Osaka, Japan.
authors.forename: Toshinori
authors.initials: T
authors.lastname: Ito
mesh_terms: D000328:Adult; D000368:Aged; D002294:Carcinoma, Squamous Cell / Q000628:therapy*; D059248:Chemoradiotherapy / Q000009:adverse effects*; D004311:Double-Blind Method; D005260:Female; D005973:Glutamine / Q000627:therapeutic use*; D006258:Head and Neck Neoplasms / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D052016:Mucositis / Q000188:drug therapy* / Q000209:etiology; D011788:Quality of Life; D016896:Treatment Outcome
chemical_list: D005973:Glutamine