Ignite Creation Date:
2024-05-06 @ 7:26 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06004063
Status:
RECRUITING
Last Update Posted:
2024-06-20
First Post:
2023-08-15
Brief Title:
Safety Tolerability and Efficacy of Enteral Nutrition Versus Paranteral Nutrition in Hematopoietic Stem Cell Transplant Patients A Pilot Randomized Controlled Study
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Safety Tolerability and Efficacy of Enteral Nutrition Versus Paranteral Nutrition in Hematopoietic Stem Cell Transplant Patients A Pilot Randomized Controlled Study
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI Request
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this research study is to learn if feeding someone after a stem cell transplant is safe and practical
Detailed Description:
Primary Objective
a To determine feasibility of administering enteral nutrition EN via NGGT in SCT population in peri-transplant period
Secondary Objectives
1 Determine the differential effects of enteral feeding versus Parenteral feeding on nutrition and quality of life
2 Determine the differential effects of enteral feeding versus parenteral feeding on survival and medical comorbidities
3 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
4 Identify differential effects on microbiome for patients co-enrolled on A Study to Collect Peripheral Blood Tissue and Bone Marrow samples from Donors and Recipients of blood and marrow transplants for Laboratory Research Protocol Lab99-062
5 Determine adverse effects of enteral feeding in this population
a To determine feasibility of administering enteral nutrition EN via NGGT in SCT population in peri-transplant period
Secondary Objectives
1 Determine the differential effects of enteral feeding versus Parenteral feeding on nutrition and quality of life
2 Determine the differential effects of enteral feeding versus parenteral feeding on survival and medical comorbidities
3 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
4 Identify differential effects on microbiome for patients co-enrolled on A Study to Collect Peripheral Blood Tissue and Bone Marrow samples from Donors and Recipients of blood and marrow transplants for Laboratory Research Protocol Lab99-062
5 Determine adverse effects of enteral feeding in this population
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2023-06448 | OTHER | NCI-CTRP Clinical Trials Registry | None |