Safety, Tolerability, and Efficacy of Enteral Nutrition Versus Standard of Care Nutrition in Hematopoietic Stem Cell Transplant Patients: A Pilot Study

Last updated: March 31, 2026
Sponsor: M.D. Anderson Cancer Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Enteral nutrition (EN)

Enteral nutrition (EN)

Standard care parenteral nutrition (PN)

Clinical Study ID

NCT06004063
2021-0116
NCI-2023-06448
  • Ages > 18
  • All Genders

Study Summary

The goal of this research study is to learn if feeding someone after a stem cell transplant is safe and practical.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

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

  3. Participants > 18 or guardians for participants < 18 are willing and able to givewritten informed consent and to comply with all of the study activities. Assent isrequired 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)

  5. MDACC protocol PA18-0130. This protocol will enable us to track physicalactivity through their receipt of a Fitbit (Pediatric Energy Balance DataRepository Protocol.) , and

  6. MDACC protocol LAB99-062 "A Study to Collect Peripheral Blood, Tissue, and BoneMarrow samples from Donors and Recipients of blood and marrow transplants forLaboratory Research" which will allow collection of stool for exploration ofthe effects of feeding on microbiome data specifically.

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

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

Exclusion

Exclusion Criteria:

  1. Patients in whom EN is contraindicated (e.g intestinal ischemia, complete bowelobstruction, or other anatomical obstructive process), or all available routes of ENare contraindicated. Surgical GT placements for the sole purpose of studyparticipation will not be entertained. See Table 1

  2. Females who are pregnant. We follow FACT guidelines. Per Foundation for theAccreditation of Cellular Therapy (FACT), female patients must have a negativepregnancy test 7 days prior to bone marrow transplant.

Study Design

Total Participants: 40
Treatment Group(s): 3
Primary Treatment: Enteral nutrition (EN)
Phase:
Study Start date:
August 04, 2023
Estimated Completion Date:
December 31, 2029

Study Description

Primary Objective:

a. To determine the feasibility, acceptability, and safety of NG tube feeding compared with patients not electing NG tube feeding.

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 MDACC protocol 2014-0938 "Longitudinal Biospecimen Acquisition for All Tumor Types And At-Risk Tissue

  5. Determine adverse effects of enteral feeding in this population

Connect with a study center

  • M D Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

  • M D Anderson Cancer Center

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

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