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. (NEPHA)

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.

Study Overview

• Status: Unknown
• Conditions: Myeloablative Allo-SCT
• Intervention / Treatment: Drug: Enteral nutrition alanyl-glutamin, Dipeptiven

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 240
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63003
    • Recruiting
    • CHU Clermont-Ferrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age between 18 and 65 years
• Men and women
• Patients undergoing myeloablative allo-SCT
• Allo-SCT genoidentical or phenoidentical 10/10
• Patients affiliated with a social security organisation
• Patients having signed the informed consent

Exclusion Criteria:

• Status of tumour progression at the moment of the allo-SCT
• Artificial nutrition begun before the inclusion
• Inability to understand the protocol (linguistic barrier, cognitive difficulties)
• Contraindication or associated pathology that does not allow to carry out EN or PN according to the protocol
• Medical history of progressive psychiatric illness
• Medical history of another progressive cancer or occurrence in the 5 previous years
• Presence of a simultaneous serious and uncontrolled disease such as severe cardiac, renal, hepatic or respiratory failure or severe sepsis
• Previous allo-SCT
• Participation in another clinical trial studying an allograft procedure, and applying modalities that are not available in routine practice (including innovative immunosuppression and graft or conditioning regimens not considered as myeloablative)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: EN (Enteral Nutrition); NE group: According to the HAS and SFNEP recommendations and the good practice rules, a polyurethane or silicone NGT, 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.	Drug: Enteral nutrition alanyl-glutamin, Dipeptiven; Enteral nutrition versus parenteral nutrition; Other Names: All patients will received, whatever treatment arm, intravenous alanyl-glutamin, Dipeptiven which have AMM.
OTHER: PN (Parenteral Nutrition); NE group: According to the HAS and SFNEP recommendations and the good practice rules, a polyurethane or silicone NGT, 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.	Drug: Enteral nutrition alanyl-glutamin, Dipeptiven; Enteral nutrition versus parenteral nutrition; Other Names: All patients will received, whatever treatment arm, intravenous alanyl-glutamin, Dipeptiven which have AMM.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mortality related to the transplant	at day 100

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of post-transplant complications targeting acute GVH, mucite and infections		12 months after AHSCT (hematopoietic stem cell transplantation)
Overall survival and disease free survival		12 months after AHSCT (hematopoietic stem cell transplantation)
Evolution of nutritional state	All patients will received, whatever treatment arm, intravenous alanyl-glutamin, Dipeptiven which have AMM.	12 months after AHSCT
Tolerance of nutritional support mainly on digestive and hepatobiliary disorders	All patients will received, whatever treatment arm, intravenous alanyl-glutamin, Dipeptiven which have AMM.	12 months after AHSCT
Engraftment rates		Day30, Day60, Day90 and Day180
quality of life assessment		Day7, Day90, Day180 and Day360

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Collaborators: Laboratoires NUTRICIA; Société Francophone Nutrition Clinique et Métabolisme; Societe Francaise de Greffe de Moelle et de Therapie Cellulaire
• Investigators: Principal Investigator: corinne Bouteloup, University Hospital, Clermont-Ferrand

Publications and helpful links

General Publications

• Lemal R, Cabrespine A, Pereira B, Combal C, Ravinet A, Hermet E, Bay JO, Bouteloup C. 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). Trials. 2015 Apr 7;16:136. doi: 10.1186/s13063-015-0663-8.

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (ANTICIPATED): July 1, 2017
• Study Completion (ANTICIPATED): July 1, 2017

Study Registration Dates

• First Submitted: July 19, 2013
• First Submitted That Met QC Criteria: October 7, 2013
• First Posted (ESTIMATE): October 8, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): July 29, 2016
• Last Update Submitted That Met QC Criteria: July 28, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Haematopoietic stem cell transplantation; Malignant hemopathy; Artificial nutrition
• Other Study ID Numbers: CHU-0165; 2011-A1288-33