Actively Recruiting
Safety, Tolerability, and Efficacy of Enteral Nutrition Versus Standard of Care Nutrition in Hematopoietic Stem Cell Transplant Patients: A Pilot Study
Led by M.D. Anderson Cancer Center · Updated on 2026-04-02
40
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying whether feeding patients after a hematopoietic stem cell transplant using a nasogastric (NG) tube is safe, practical, and acceptable compared to standard nutrition care. This pilot study aims to evaluate the effects of enteral feeding versus parenteral feeding on nutrition, quality of life, survival, medical complications, physical activity, and the gut microbiome in transplant patients. The study is sponsored by M.D. Anderson Cancer Center and involves patients who have planned or current inpatient transplant admission. Participants are randomly assigned to one of two groups. One group receives enteral nutrition delivered directly into the stomach through a nasogastric tube, with dietician monitoring and possible supplemental feeding by vein to meet calorie needs. The other group receives standard care nutrition, which may include oral supplements or parenteral feeding by vein if oral intake is insufficient. The feeding approach depends on the patient's ability to meet caloric goals by mouth. During the study, researchers monitor participants for adverse events using standard criteria, with follow-up for about one year. Dieticians regularly assess nutrition and caloric intake. Additional data such as physical activity from Fitbit devices and stool samples for microbiome analysis may be collected from patients enrolled in related protocols. The study tracks safety, tolerability, quality of life, survival, and medical outcomes to better understand nutrition strategies after stem cell transplant.
CONDITIONS
Brief Title
Safety, Tolerability, and Efficacy of Enteral Nutrition Versus Standard of Care Nutrition in Hematopoietic Stem Cell Transplant Patients: A Pilot Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Plans to be admitted or currently admitted for hematopoietic stem cell transplant in an inpatient pediatric or adult ward
- Age greater than 2 years and less than 25 years at time of enrollment
- Participants older than 18 or guardians for participants younger than 18 are willing and able to give written informed consent; assent is required for children older than 7 years
- Participants must speak English, Italian, Chinese/Mandarin, or Spanish
- Encouraged to co-enroll in related energy-balance protocols, though not required
- Asked to consider co-enrollment on a stem cell registry study (not required)
You will not qualify if you...
- Patients for whom enteral nutrition is contraindicated, such as those with intestinal ischemia or complete bowel obstruction
- Surgical gastrostomy tube placements solely for study participation are not allowed
- Female participants who are pregnant, confirmed by a negative pregnancy test within 7 days before transplant according to FACT guidelines
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 year or until study completion
Participants receive either enteral nutrition through a nasogastric tube or standard care parenteral nutrition by vein, monitored by a dietician to meet daily caloric needs.
Regular dietician monitoring visits throughout treatment period
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
S
Shehla Razvi, MD
K
Karen Moody, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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