Randomized, Prospective, Multicenter Study to Compare Enteral Nutrition to Parenteral Nutrition as Feeding Support in Patients Presenting Malignant Hemopathy Who Underwent an Allogeneic Hematopoietic Stem Cell Transplantation.

NCT ID: NCT01955772


Title
Purpose
Myeloablative allogeneic hematopoetic stem cell transplantation (AHSCT) are prone to frequent secondary malnutrition to metabolic and digestive troubles due to conditioning regimen, treatments (antibiotics, immunosuppressive therapy…) and graft complications (graft versus host disease). In the absence of appropriate nutritional support, myeloablative conditioning lead to a rapid serious denutrition. But, it is known as negative independent prognostic factor of overall survival of patients who presented malignant hemopathy treated by high-dose chemotherapy or AHSCT. Furthermore, it increases hospitalisation delay and decreases quality of life. In AHSCT with myeloablative conditioning, introduction of nutritional support is recommended. However, type of nutritional support remains not clearly defined. Parenteral nutrition is user but favour infections and secondary effects potentially decrease by intravenous glutamine. Few previous studies with low number of patients, mainly retrospective or combining allo-and auto HSCT had shown feasibility, acceptable tolerance and low cost of enteral nutrition (EN). A recent prospective no-randomized study in 45 adults patients who had undergone AHSCT with myeloablative conditioning find a significant decrease of day-100 mortality (5% vs 30%), of infection mortality, of median duration of parenteral nutrition (PN) and prevalence of GvH (Graft versus Host Disease) grade III-IV in EN (enteral nutrition) group. These results had to be confirmed by a randomized study. As EN is 4 to 5 more cheaply than PN, besides mortality/morbidity stakes for the patient, this study could have potential economic interest.
Details
EN (enteral nutrition) or PN (parenteral nutrition) artificial nutrition will be launched at D1-D2 of the transplantation (D0 being the day of the transplantation),without taking into account the oral intake. This helps in particular to launch the EN after the stage of significant digestive problems related to the conditioning and before the mucositis appearance. EN group: According to the HAS and SFNEP (Societe francophone nutrition clinique) recommendations and the good practice rules, a polyurethane or silicone NGT(Naso gastric tube), 8 to 10 French units, will be inserted and its positioning will be controlled by radiography before the EN beginning. Polyurethane and silicone are very well tolerated by nasal and oesophagus mucosa and have a long life duration allowing keeping the same tube during 2 to 3 months. PN group: PN will be administrated by a central venous catheter, which is usually inserted in allo-HSCT patients to allow the administration of chemotherapy and of the different parenteral treatments.
Conditions
Myeloablative Allo-SCT
Keywords
Haematopoietic stem cell transplantation, Malignant hemopathy, Artificial nutrition
Source
University Hospital, Clermont-Ferrand
Sponsors
University Hospital, Clermont-Ferrand, Societe Francaise de Greffe de Moelle et de Therapie Cellulaire, Société Francophone Nutrition Clinique et Métabolisme, Laboratoires NUTRICIA
Status
Recruiting
Acronym
NEPHA
Last Updated
27 Jul 2016
URL
Official Link
Locations
France