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

NCT06004063 | Recruiting DMC

• 2 other identifiers: 2021-0116NCI-2023-06448
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Enteral nutrition (EN)-Group 1

EXPERIMENTAL

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.

Dietary Supplement: Enteral nutrition (EN); Other: Standard care parenteral nutrition (PN)

Standard care parenteral nutrition (PN)-Group 2

ACTIVE COMPARATOR

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.

Other: Standard care parenteral nutrition (PN)

Interventions

Enteral nutrition (EN) DIETARY_SUPPLEMENT

Given by Nasogastric Tube

Enteral nutrition (EN)-Group 1

Standard care parenteral nutrition (PN) OTHER

Given by PO or Given by IV (vein)

Enteral nutrition (EN)-Group 1; Standard care parenteral nutrition (PN)-Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have plans to be admitted or be admitted to an inpatient pediatric or adult ward for the purpose of HSCT.
• Be greater than 2 years of age and less than 25 years of age at time of study enrollment.
• 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
• Participants will be encouraged to co-enroll on two additional related energy -balance protocols (highly encouraged but not required)
• 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
• 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.
• Participants will be asked to consider co-enrollment on Stem Cell Registry study (not required):
• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• M D Anderson Cancer Center

MeSH Terms

Interventions

Enteral Nutrition

Intervention Hierarchy (Ancestors)

Feeding Methods; Therapeutics; Nutritional Support; Nutrition Therapy

Study Officials

• Shehla Razvi, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shehla Razvi, MD

CONTACT

(713) 792-6635; srazvi@mdanderson.org

Karen Moody, MD

CONTACT

713-792-6610; kmoody@mdanderson.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2023
• First Posted: August 22, 2023
• Study Start: August 4, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2029
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)