RecruitingNot ApplicableNCT06004063

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

Sponsor

M.D. Anderson Cancer Center

Enrollment

40 participants

Start Date

Aug 4, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

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.

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.

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