This clinical trial evaluates whether feeding directly into the stomach using a tube (enteral nutrition) improves health outcomes in patients undergoing a hematopoietic stem cell transplant. Stem cell transplant recipients are at increased risk for significant malnutrition, which can lead to increased time to blood cell count recovery, increased risk for graft-versus-host disease (GVHD) and death. Total parenteral nutrition (TPN) is the current standard for nutritional supplementation when patients are unable to meet daily nutritional requirements by mouth. TPN is a liquid mixture of proteins, carbohydrates, fats, vitamins, minerals and other nutrients that is given through the vein. However, there are several disadvantages to the use of TPN, including increased risk of infection, high blood sugar and insulin resistance, and liver disease. Enteral feeding may be a safe and effective alternative to TPN for nutritional support in stem cell transplant patients. This study may help researchers learn whether enteral feeding after transplant may improve transplant-related health outcomes such as reduced infection, earlier blood cell count recovery, less GVHD, and better quality of life compared to only TPN.
Additional locations may be listed on ClinicalTrials.gov for NCT06004063.
Locations matching your search criteria
United States
Texas
Houston
M D Anderson Cancer CenterStatus: Active
Contact: Shehla Razvi
Phone: 713-792-6635
PRIMARY OBJECTIVE:
I. To determine the feasibility, acceptability, and safety of nasoenteric (NG) tube feeding compared with patients not electing NG tube feeding.
SECONDARY OBJECTIVES:
I. Determine the differential effects of enteral feeding versus parenteral feeding on nutrition, and quality of life.
II. Determine the differential effects of enteral feeding versus parenteral feeding on survival and, medical comorbidities.
III. Determine the differential effects of enteral feeding versus parenteral feeding on Fitbit data study for patients co-enrolled in Pediatric Energy Balance Data Repository Protocol PA18-0130.
IV. Identify differential effects on microbiome for patients co-enrolled on MDACC protocol 2014-0938 “Longitudinal Biospecimen Acquisition for All Tumor Types And At-Risk Tissue.
V. Determine adverse effects of enteral feeding in this population.
OUTLINES: Patients are randomized to 1 of 2 groups.
GROUP I: Patients receive EN via NG or nasoduodenal (ND) for 12 hours overnight, based on daily caloric intake goals, starting on day of admission and ending post-stem cell transplant. Patients may recieve standard of care (SOC) parenteral nutrition (PN) intravenously (IV) based on caloric intake goals per the discretion of the treating physician.
GROUP II: Patients may recieve SOC PN IV based on daily caloric intake goals per the discretion of the treating physician.
After completion of study intervention, patients will be followed up to 100 days after transplant.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorShehla Razvi
