Recruiting

Enteral Nutrition vs. Parenteral Nutrition

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT06004063

Conditions

Stem Cell

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Enteral nutrition (EN)

Standard care parenteral nutrition (PN)

Study Details

Brief summary:

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

Conditions

Stem Cell

Study ID

NCT06004063

Start date

Aug 4, 2023

Status verified date

Mar, 2026

Completion date

Dec 31, 2029

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Enteral nutrition (EN)-Group 1

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.

active comparator: Standard care parenteral nutrition (PN)-Group 2

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.

Interventions

Enteral nutrition (EN)

Given by Nasogastric Tube

Standard care parenteral nutrition (PN)

Given by PO or Given by IV (vein)

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Locations

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Apr 2, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-04-02.