About this trial
The goal of this research study is to learn if feeding someone after a stem cell transplant is safe and practical.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Participants will be encouraged to co-enroll on two additional related energy -balance protocols (highly encouraged but not required)
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Enteral nutrition (EN)
Dietary supplementGiven by Nasogastric Tube
Standard care parenteral nutrition (PN)
Other interventionGiven by PO or Given by IV (vein)
Treatment groups
Trial outcomes
Primary outcomes
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Sponsors and contacts
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