title: Could enteral nutrition improve the outcome of patients with haematological malignancies undergoing allogeneic haematopoietic stem cell transplantation? A study protocol for a randomized controlled trial (the NEPHA study).
abstract: BACKGROUND
  Myeloablative allogeneic haematopoietic stem cell transplantation (allo-HSCT) is a major procedure usually accompanied by multifactorial malnutrition, prompting the recommendation of systematic artificial nutritional support. Parenteral nutrition (PN) is usually administered during allo-HSCT, essentially for practical reasons. Recently published data suggest that enteral nutrition (EN), given as systematic artificial nutrition support, could decrease grade III-IV graft-versus-host disease (GVHD) and infectious events, which are associated with early toxicity after allo-HSCT and then have an impact on early transplant-related mortality (D100 mortality).
  
  
  METHODS
  We report on the NEPHA trial: an open-label, prospective, randomised, multi-centre study on two parallel groups, which has been designed to evaluate the effect of EN compared to PN on early toxicity after an allo-HSCT procedure. Two hundred forty patients treated with allo-HSCT for a haematological malignancy will be randomly assigned to two groups to receive either EN or PN. The primary endpoint will assess the effect of EN on D100 mortality. Secondary endpoints will compare EN and PN with regards to the main haematological, infectious and nutritional outcomes.
  
  
  CONCLUSIONS
  The impacts of nutritional support should exceed the limits of nutritional status improvement: EN may directly reduce immunological and infectious events, as well as decrease early transplant-related morbidity and mortality. EN and PN need to be prospectively compared in order to assess their impacts and to provide treatment guidelines. (Clinical trials gov number: NCT01955772; registration: July 19th, 2013).
authors: CHU Clermont-Ferrand, Service d'Hématologie Clinique Adulte et de Thérapie Cellulaire, F-63003, Clermont-Ferrand, France. rlemal@chu-clermontferrand.fr.|Clermont Université, Université d'Auvergne, EA7283, CIC501, BP 10448, F-63000, Clermont-Ferrand, France. rlemal@chu-clermontferrand.fr.
authors: Richard
authors: R
authors: Lemal
authors: CHU Clermont-Ferrand, Service d'Hématologie Clinique Adulte et de Thérapie Cellulaire, F-63003, Clermont-Ferrand, France. acabrespine@chu-clermontferrand.fr.|Clermont Université, Université d'Auvergne, EA7283, CIC501, BP 10448, F-63000, Clermont-Ferrand, France. acabrespine@chu-clermontferrand.fr.
authors: Aurélie
authors: A
authors: Cabrespine
authors: CHU Clermont-Ferrand, Unité biostatistique Direction de la Recherche Clinique, F-63003, Clermont-Ferrand, France. bpereira@chu-clermontferrand.fr.
authors: Bruno
authors: B
authors: Pereira
authors: CHU Clermont-Ferrand, Service Diététique, F-63003, Clermont-Ferrand, France. ccombal@chu-clermontferrand.fr.
authors: Cécile
authors: C
authors: Combal
authors: CHU Clermont-Ferrand, Service d'Hématologie Clinique Adulte et de Thérapie Cellulaire, F-63003, Clermont-Ferrand, France. aravinet@chu-clermontferrand.fr.|Clermont Université, Université d'Auvergne, EA7283, CIC501, BP 10448, F-63000, Clermont-Ferrand, France. aravinet@chu-clermontferrand.fr.
authors: Aurélie
authors: A
authors: Ravinet
authors: CHU Clermont-Ferrand, Service d'Hématologie Clinique Adulte et de Thérapie Cellulaire, F-63003, Clermont-Ferrand, France. ehermet@chu-clermontferrand.fr.|Clermont Université, Université d'Auvergne, EA7283, CIC501, BP 10448, F-63000, Clermont-Ferrand, France. ehermet@chu-clermontferrand.fr.
authors: Eric
authors: E
authors: Hermet
authors: CHU Clermont-Ferrand, Service d'Hématologie Clinique Adulte et de Thérapie Cellulaire, F-63003, Clermont-Ferrand, France. jobay@chu-clermontferrand.fr.|Clermont Université, Université d'Auvergne, EA7283, CIC501, BP 10448, F-63000, Clermont-Ferrand, France. jobay@chu-clermontferrand.fr.
authors: Jacques-Olivier
authors: JO
authors: Bay
authors: CHU Clermont-Ferrand, Service de Médecine Digestive et Hépatobiliaire, F-63003, Clermont-Ferrand, France. cbouteloup@chu-clermontferrand.fr.|Clermont Université, Université d'Auvergne, Unité de Nutrition Humaine, BP 10448, F-63000, Clermont-Ferrand, France. cbouteloup@chu-clermontferrand.fr.|INRA, UMR 1019, UNH, CRNH Auvergne, F-63000, Clermont-Ferrand, France. cbouteloup@chu-clermontferrand.fr.
authors: Corinne
authors: C
authors: Bouteloup
mesh_terms: D004750:Enteral Nutrition; D019337:Hematologic Neoplasms / Q000401:mortality / Q000628:therapy*; D018380:Hematopoietic Stem Cell Transplantation; D006801:Humans; D010288:Parenteral Nutrition; D011446:Prospective Studies