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

ConditionStem Cell
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

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

Qualifiers

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

Treatments tested in this trial

  • Enteral nutrition (EN)
  • Standard care parenteral nutrition (PN)

Treatment groups

40 Participants
are divided into 2 treatment groups

Sponsors and collaborators