Safety, Tolerability, and Efficacy of Enteral Nutrition Versus Paranteral Nutrition in Hematopoietic Stem Cell Transplant Patients: A Pilot Randomized Controlled Study

Launched by M.D. ANDERSON CANCER CENTER · Aug 15, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at two ways to provide nutrition to patients who have had a stem cell transplant: through a feeding tube into the stomach (enteral nutrition) or through an intravenous line (parenteral nutrition). The main goal is to find out if these methods are safe and effective for helping patients recover after their transplant. The study is currently recruiting participants aged between 2 and 25 years who are being treated in a hospital for a stem cell transplant.

To be eligible, participants must be able to give consent or have their guardians do so, and they should be able to speak English, Italian, Chinese/Mandarin, or Spanish. Participants will be monitored closely and may also be encouraged to join additional related studies, although this is not required. By taking part in this study, patients will help researchers learn more about the best ways to support recovery after stem cell transplants, which could benefit future patients.

Gender

ALL

Eligibility criteria

• 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.