A Phase II Randomized Trial of Enteral Nutrition Versus Standard of Care in Allogeneic Hematopoietic Stem Cell Transplantation (ENABLE-1)
Categories (click each to see list of all clinical trials associated with that category): BMT/GVHD (ONC), FPBCC CTO Studies, Leukemia/MDS/MPD (ONC), Lymphoma/CLL (ONC), Myeloma/Plasma Cell Dyscrasia (ONC)
Current Status: Not open
Phase: II
Principal Investigator: Haddadin, Michael
Contact Information:
Michael Haddadin
mihaddadin@unmc.edu
Summary
Primary Objective
The primary objective of this randomized controlled trial is to compare the rate of stage 3-4 acute GVHD of the
lower gut after allogeneic hematopoietic stem cell transplant in the early enteral nutrition (study) versus the
standard of care (control) group.
Secondary Objectives
1) To compare the rates of stage 2-4 acute GVHD of the lower gut by day +100 after transplant
2) To examine the cumulative incidence of grade 2-4 acute GVHD during the first 100 days after transplant
3) To evaluate changes in weight and lean muscle mass over the course of the first 100 days after transplant
4) To assess changes in physical function from baseline to day +100 after transplant
5) To estimate changes in health-related quality of life from baseline to day +100 after transplant
6) To determine the length of transplant admission hospital stay
7) To assess the number of days until neutrophil and platelet engraftment
Exploratory Objective
1) To examine alterations in stool microbiota before and after allo-HSCT