title: Efficacy of glutamine in the prevention of acute radiation enteritis: a randomized controlled trial.
abstract: BACKGROUND
  Acute radiation enteritis is a common adverse effect related to radiotherapy (RT). Glutamine is an immune modulator and antioxidant amino acid that can exert a protective role in patients receiving abdominal or pelvic radiation. The aim of this study was to test if glutamine prevents radiation enteritis during RT.
  
  
  METHODS
  Double-blind, randomized, controlled trial including 69 patients who needed RT because of pelvic or abdominal malignancies and received glutamine (30 g/d) or placebo (casein, 30 g/d). Enteritis was evaluated according to the Radiation Therapy Oncology Group scale, intestinal inflammation using fecal calprotectin, and gut integrity with citrulline. The incidence of enteritis was analyzed by Kaplan-Meier curves, and the hazard ratio (HR) was calculated using Cox regression.
  
  
  RESULTS
  Patients were predominantly male (65.2%), with an average (SD) age of 66.6 (9.9) years, with urologic (44.9%), rectal (24.6%), or gynecological cancer (23.1%). More patients developed enteritis with glutamine than with the placebo (55.9% vs 22.0%; P = .002), with an HR OF 1.59 (95% confidence interval, 0.624.05). There were no differences in final calprotectin levels (glutamine, 57.9 [85.8] mg/kg vs placebo, 54.0 [57.7] mg/kg; p = .182) or the number of patients with values 50 mg/kg (glutamine, 58.1% vs placebo, 54.6%; p = .777). Final citrulline levels were similar between groups (glutamine, 26.31 [10.29] mmol/l vs placebo, 27.69 [12.31] mmol/l; p = .639), without differences in the number of patients with 20 mmol/l (glutamine, 24.1% vs placebo, 25.0%; P = .938). Citrulline concentration was reduced during rt with placebo but remained unchanged with glutamine.
  
  
  CONCLUSIONS
  Glutamine does not prevent the development of enteritis during RT.
authors.affiliation: Sección de Endocrinología y Nutrición, Complejo Asistencial Universitario de León, Spain.
authors.forename: Alfonso
authors.initials: A
authors.lastname: Vidal-Casariego
authors.forename: Alicia
authors.initials: A
authors.lastname: Calleja-Fernández
authors.forename: Juan José Ortiz
authors.initials: JJ
authors.lastname: de Urbina-González
authors.forename: Isidoro
authors.initials: I
authors.lastname: Cano-Rodríguez
authors.forename: Fernando
authors.initials: F
authors.lastname: Cordido
authors.forename: María D
authors.initials: MD
authors.lastname: Ballesteros-Pomar
mesh_terms: D000208:Acute Disease; D000368:Aged; D002956:Citrulline / Q000097:blood; D004311:Double-Blind Method; D004751:Enteritis / Q000473:pathology / Q000517:prevention & control*; D005260:Female; D005973:Glutamine / Q000494:pharmacology*; D006801:Humans; D007249:Inflammation / Q000188:drug therapy; D007413:Intestinal Mucosa / Q000473:pathology / Q000528:radiation effects*; D007422:Intestines / Q000473:pathology / Q000528:radiation effects*; D039841:Leukocyte L1 Antigen Complex / Q000097:blood; D008297:Male; D008875:Middle Aged; D015596:Nutrition Assessment; D009752:Nutritional Status; D016016:Proportional Hazards Models; D011878:Radiotherapy / Q000009:adverse effects*
chemical_list: D039841:Leukocyte L1 Antigen Complex; D005973:Glutamine; D002956:Citrulline
keywords: acute radiation enteritis; calprotectin; citrulline; glutamine; nitric oxide