title: Effects of oral glutamine during abdominal radiotherapy on chronic radiation enteritis: a randomized controlled trial.
abstract: OBJECTIVE
  Glutamine has been proposed as a preventive treatment for toxicity related to cancer therapies. The aim of this study was to test the efficacy of glutamine in the prevention of radiation enteritis.
  
  
  METHODS
  A randomized, double-blind, controlled trial was performed including 69 patients who were assigned to receive either glutamine (Gln, 30 g/d) or placebo while they were receiving abdominal radiotherapy. Patients were re-evaluated 1 y after completion of treatment. The presence of chronic enteritis was assessed using the Radiation Therapy Oncology Group scale. Nutritional status was evaluated using subjective global assessment, weight, and bioimpedance. Relative risk (RR) and its confidence interval (CI) were also calculated.
  
  
  RESULTS
  The trial initially included 69 patients (34 Gln, 35 placebo), but 11 patients were lost during follow-up (4 Gln, 7 placebo; P = 0.296). Chronic enteritis was developed by 14 % of patients: Gln 16.7 % versus placebo 11.1% (RR = 1.33; 95% CI, 0.35-5.03; P = 0.540). Most cases of enteritis were grade I (75%), with no differences between groups. The stool frequency increased after radiotherapy in patients who received Gln (from 1 ± 1 to 2 ± 2 stools per day, P = 0.012), but remained unchanged with placebo (1 ± 1 stools per day, P = 0.858; difference between groups P = 0.004). There were no differences between the two groups in terms of weight, fat mass, or fat-free mass index, or between patients with enteritis and those without intestinal toxicity.
  
  
  CONCLUSIONS
  Chronic enteritis is a relatively infrequent phenomenon, and Gln administration during radiotherapy does not exert a protective effect.
authors.affiliation: Sección de Endocrinología y Nutrición, Complejo Asistencial Universitario de León, León, Spain. Electronic address: avcyo@hotmail.com.
authors.forename: Alfonso
authors.initials: A
authors.lastname: Vidal-Casariego
authors.affiliation: Sección de Endocrinología y Nutrición, Complejo Asistencial Universitario de León, León, Spain.
authors.forename: Alicia
authors.initials: A
authors.lastname: Calleja-Fernández
authors.affiliation: Sección de Endocrinología y Nutrición, Complejo Asistencial Universitario de León, León, Spain.
authors.forename: Isidoro
authors.initials: I
authors.lastname: Cano-Rodríguez
authors.affiliation: Departamento de Medicina, Universidad de A Coruña, A Coruña, Spain.
authors.forename: Fernando
authors.initials: F
authors.lastname: Cordido
authors.affiliation: Sección de Endocrinología y Nutrición, Complejo Asistencial Universitario de León, León, Spain.
authors.forename: María D
authors.initials: MD
authors.lastname: Ballesteros-Pomar
mesh_terms: D000284:Administration, Oral; D000368:Aged; D002908:Chronic Disease; D004305:Dose-Response Relationship, Drug; D004307:Dose-Response Relationship, Radiation; D004311:Double-Blind Method; D004751:Enteritis / Q000188:drug therapy*; D005260:Female; D041981:Gastrointestinal Tract / Q000187:drug effects / Q000528:radiation effects*; D005973:Glutamine / Q000008:administration & dosage*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000188:drug therapy / Q000532:radiotherapy; D009752:Nutritional Status; D011878:Radiotherapy / Q000009:adverse effects*
chemical_list: D005973:Glutamine
keywords: Chemotherapy; Chronic radiation enteritis; Glutamine; Radiotherapy