title: A phase III study evaluating oral glutamine and transforming growth factor-beta 2 on chemotherapy-induced toxicity in patients with digestive neoplasm.
abstract: BACKGROUND
  Patients with gastrointestinal (GI) cancer are exposed to cachexia, which is highly correlated with chemotherapy-induced side effects. Research suggests that specific immunonutrients could prevent such toxicities.
  
  
  OBJECTIVE
  The primary objective of this phase III study was to evaluate the efficacy of glutamine and transforming growth factor-β2 (TGF-β2) in the prevention of grade 3-4 non-hematological toxicities induced by chemotherapy in patients with GI cancer.
  
  
  METHODS
  We designed a double-blind, randomized, controlled and multicenter trial stratified according to center, type of chemotherapy, presence of cachexia, and age. Patients were randomized to receive either Clinutren Protect(®) (CP) or a control isocaloric diet (without TGF-β2 or glutamine).
  
  
  RESULTS
  Between November 2007 and October 2011, 210 patients were enrolled in the study, of which 201 were included in the intention-to-treat analysis. Grade 3-4 non-hematological toxicities were not significantly different between the CP and control groups when evaluated by univariate and multivariate analyses. Likewise, no difference was observed regarding grade 3-4 hematological toxicities or reasons for treatment interruption.
  
  
  CONCLUSIONS
  This randomized study does not support the hypothesis that oral glutamine and TGF-β2 supplementation is effective to reduce grade 3 or 4 non-hematological toxicities induced by chemotherapy in patients with GI neoplasm.
authors.affiliation: Gastroenterology Department, Centre Hospitalier de Perpignan, Perpignan, France.
authors.forename: Faïza
authors.initials: F
authors.lastname: Khemissa
authors.affiliation: Digestive Oncology and Radiotherapy Unit, Institut Sainte Catherine, Avignon Cedex 9, Avignon, France.
authors.forename: Laurent
authors.initials: L
authors.lastname: Mineur
authors.affiliation: Nutrition Department, INSERM U1073, Institut de Recherche et d'Innovation Biomédicale, Université de Rouen, Rouen, France.
authors.forename: Caroline
authors.initials: C
authors.lastname: Amsellem
authors.affiliation: Department of Clinical Nutrition and Gastroenterology, Institut régional du Cancer de Montpellier (ICM), Montpellier, France.
authors.forename: Eric
authors.initials: E
authors.lastname: Assenat
authors.affiliation: Gastroenterology Department, Centre Hospitalier de Béziers, Béziers, France.
authors.forename: Mohamed
authors.initials: M
authors.lastname: Ramdani
authors.affiliation: Department of Clinical Nutrition, Centre Léon Bérard, Lyon, France.
authors.forename: Patrick
authors.initials: P
authors.lastname: Bachmann
authors.affiliation: Clinical Research Department, Institut régional du Cancer de Montpellier (ICM), Montpellier, France.
authors.forename: Chloé
authors.initials: C
authors.lastname: Janiszewski
authors.affiliation: Nestlé Research Centre, Lausanne 26, Switzerland.
authors.forename: Isabelle
authors.initials: I
authors.lastname: Cristiani
authors.affiliation: Clinical Research Department, Centre Hospitalier de Perpignan, Perpignan, France.
authors.forename: Fideline
authors.initials: F
authors.lastname: Collin
authors.affiliation: Clinical Research Department, Institut régional du Cancer de Montpellier (ICM), Montpellier, France.
authors.forename: Julie
authors.initials: J
authors.lastname: Courraud
authors.affiliation: Clinical Research Department, Institut régional du Cancer de Montpellier (ICM), Montpellier, France.
authors.forename: Hélène
authors.initials: H
authors.lastname: de Forges
authors.affiliation: Nutrition Department, INSERM U1073, Institut de Recherche et d'Innovation Biomédicale, Université de Rouen, Rouen, France.
authors.forename: Pierre
authors.initials: P
authors.lastname: Dechelotte
authors.affiliation: Department of Clinical Nutrition and Gastroenterology, Institut régional du Cancer de Montpellier (ICM), Montpellier, France; SIRIC Montpellier Cancer, Institut régional du Cancer de Montpellier (ICM), Montpellier, France; Epsylon Laboratory, EA 4556 Dynamics of Human Abilities & Health Behaviors, Université de Montpellier, Montpellier, France. Electronic address: Pierre.Senesse@icm.unicancer.fr.
authors.forename: Pierre
authors.initials: P
authors.lastname: Senesse
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects*; D002100:Cachexia / Q000150:complications; D019587:Dietary Supplements; D004311:Double-Blind Method; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D005767:Gastrointestinal Diseases / Q000139:chemically induced* / Q000517:prevention & control*; D005770:Gastrointestinal Neoplasms / Q000150:complications / Q000188:drug therapy*; D005973:Glutamine / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D017671:Platinum Compounds / Q000008:administration & dosage; D016212:Transforming Growth Factor beta / Q000627:therapeutic use*
chemical_list: D017671:Platinum Compounds; D016212:Transforming Growth Factor beta; D005973:Glutamine; D005472:Fluorouracil
keywords: Chemotherapy; Gastrointestinal cancer; Immunonutrition; Side effects