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
Other study identifiers
Sponsor study identifier
Secondary identifiers
interventional
240
1 country
1
Study Start
November 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry Overview
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
- Recruitment status
- unknown
- Estimated enrollment
- 240 participants
- Study completion date
July 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
- Listed locations
- 1 countries · 1 sites
Trial Relationships
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Study Timeline
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
First Submitted
July 19, 2013
Actual (reported)First Posted
October 8, 2013
Actual (reported)Study Start
November 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
- Last Updated
- July 29, 2016
- Status Verified
- July 2016
- Last Update Submitted
- July 28, 2016