Safety, Tolerability, and Efficacy of Enteral Nutrition Versus Paranteral Nutrition in Hematopoietic Stem Cell Transplant Patients: A Pilot Randomized Controlled Study

Not Applicable

Recruiting

• Conditions: Stem Cell
• Interventions: Dietary Supplement: Enteral nutrition (EN); Other: Standard care parenteral nutrition (PN)

• Registration Number: NCT06004063
• Lead Sponsor: M.D. Anderson Cancer Center

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 NG/GT 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 Timeline

• Study Start: 2023-08-04
• Study First Submitted: 2023-08-15
• Study First Submitted QC: 2023-08-15
• Study First Posted: 2023-08-22
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-20
• Primary Completion: 2027-12-31
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Have plans to be admitted or be admitted to an inpatient pediatric or adult ward for the purpose of HSCT.

2. Be greater than 2 years of age and less than 25 years of age at time of study enrollment.

3. Participants > 18 or guardians for participants < 18 are willing and able to give written informed consent and to comply with all of the study activities. Assent is required for children > 7 years old.

   a) Participants must be English, Italian, Chinese/Mandarin, or Spanish speaking

4. Participants will be encouraged to co-enroll on two additional related energy -balance protocols (highly encouraged but not required)

   1. MDACC protocol PA18-0130. This protocol will enable us to track physical activity through their receipt of a Fitbit (Pediatric Energy Balance Data Repository Protocol.) , and
   2. MDACC protocol LAB99-062 "A Study to Collect Peripheral Blood, Tissue, and Bone Marrow samples from Donors and Recipients of blood and marrow transplants for Laboratory Research" which will allow collection of stool for exploration of the effects of feeding on microbiome data specifically.

5. Participants will be asked to consider co-enrollment on Stem Cell Registry study (not required):

   1. PA19-0756: This is a prospective multi-center study to understand the contribution of vascular endothelial dysfunction towards morbidity and mortality among children and adolescents/young adults (AYA) undergoing HCT/CT.

Exclusion Criteria

1. Patients in whom EN is contraindicated (e.g intestinal ischemia, complete bowel obstruction, or other anatomical obstructive process), or all available routes of EN are contraindicated. Surgical GT placements for the sole purpose of study participation will not be entertained. See Table 1
2. Females who are pregnant. We follow FACT guidelines. Per Foundation for the Accreditation of Cellular Therapy (FACT), female patients must have a negative pregnancy test 7 days prior to bone marrow transplant.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enteral nutrition (EN)-Group 1	Standard care parenteral nutrition (PN)	Participants will receive enteral feeding (directly into the stomach) based on your ability to receive your daily caloric needs by mouth. Participants will be monitored by a dietician and may receive feeding by vein to achieve caloric goals.
Enteral nutrition (EN)-Group 1	Enteral nutrition (EN)	Participants will receive enteral feeding (directly into the stomach) based on your ability to receive your daily caloric needs by mouth. Participants will be monitored by a dietician and may receive feeding by vein to achieve caloric goals.
Standard care parenteral nutrition (PN)-Group 2	Standard care parenteral nutrition (PN)	Participants will receive the standard of care. Participants will be monitored by a dietician to see if the participants are able to receive your daily caloric needs by mouth. Some participants may be able to receive oral dietary supplements, but if this is not possible or not enough, participants will begin receiving standard of care feeding by vein.

Primary Outcome Measures

Name	Time	Method
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0	through study completion; an average of 1 year.

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States