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.

NCT01955772 | Unknown Phase 3

• 2 other identifiers: CHU-01652011-A1288-33
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Myeloablative Allo-SCT

Keywords

Haematopoietic stem cell transplantation; Malignant hemopathy; Artificial nutrition

Outcome Measures

Primary Outcomes (1)

• Mortality related to the transplant

  at day 100

Secondary Outcomes (6)

• 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

  12 months after AHSCT

• Tolerance of nutritional support mainly on digestive and hepatobiliary disorders

  12 months after AHSCT

• Engraftment rates

  Day30, Day60, Day90 and Day180

Study Arms (2)

EN (Enteral Nutrition)

EXPERIMENTAL

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

PN (Parenteral Nutrition)

OTHER

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

Interventions

Enteral nutrition alanyl-glutamin, Dipeptiven DRUG

Enteral nutrition versus parenteral nutrition

Also known as: All patients will received, whatever treatment arm, intravenous alanyl-glutamin, Dipeptiven which have AMM.

EN (Enteral Nutrition); PN (Parenteral Nutrition)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Status of tumour progression at the moment of the allo-SCT
• 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)

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• Societe Francaise de Greffe de Moelle et de Therapie Cellulaire: collaborator
• Société Francophone Nutrition Clinique et Métabolisme: collaborator
• Laboratoires NUTRICIA: collaborator

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

Related Publications (1)

• 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.

  PMID: 25872934 DERIVED

MeSH Terms

Interventions

alanylglutamine

Study Officials

• Corinne BOUTELOUP

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick LACARIN

CONTACT

04 73 75 11 95; placarin@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2013
• First Posted: October 8, 2013
• Study Start: November 1, 2013
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: July 29, 2016

Record last verified: 2016-07

Locations

FR (1)