Comparing enteral and parenteral nutrition in stem cell transplant patients
Safety, Tolerability, and Efficacy of Enteral Nutrition Versus Standard of Care Nutrition in Hematopoietic Stem Cell Transplant Patients: A Pilot Study
This study is testing whether feeding patients through their digestive system works better than feeding them through an IV during stem cell transplants to see how it affects their health and recovery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT06004063 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 2 to 25 years who are scheduled for hematopoietic stem cell transplantation and can provide informed consent or assent.
Not a fit: Patients outside the age range of 2 to 25 years or those not undergoing HSCT may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve nutritional support strategies for patients undergoing stem cell transplants, potentially enhancing recovery and quality of life.
How similar studies have performed: While similar studies have explored nutritional approaches in transplant populations, this specific comparison of enteral versus parenteral nutrition is novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Houston, Texas
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.