Comparing enteral and parenteral nutrition in stem cell transplant patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot study aims to evaluate the safety and feasibility of administering enteral nutrition (EN) compared to parenteral nutrition (PN) in patients undergoing hematopoietic stem cell transplantation (HSCT). The primary objective is to assess the practicality of EN during the peri-transplant period. Secondary objectives include examining the effects of both feeding methods on nutrition, quality of life, survival, medical comorbidities, and microbiome changes. Participants will also be encouraged to co-enroll in related protocols to track physical activity and collect biological samples.

Why it matters

Who can join: the full rules

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.

Where it's running

• M D Anderson Cancer Center
  Houston, Texas, United States Recruiting

Study contacts

• Principal investigator: Shehla Razvi, MD — M.D. Anderson Cancer Center
• Study coordinator: Shehla Razvi, MD
• Email: srazvi@mdanderson.org
• Phone: (713) 792-6635

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.