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RECRUITING Phase 2 ClinicalTrials.gov

Enteral Nutrition Versus Standard of Care in Allogeneic Hematopoietic Stem Cell Transplantation

Sponsor: University of Nebraska • ClinicalTrials.gov ID: NCT07315165

Registry updated: 2026-08-31
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Description

This is a randomized controlled phase II trial which will enroll 112 patients with a diagnosis of a blood cancer or a serious blood disorder who plan to undergo an allogenic hematopoietic stem cell transplant using any conditioning regimen or graft source. Eligible patients will be randomized to receive standard of care (e.g., initiation of supplemental nutrition when oral intake declines) versus enteral nutrition via enteral feeding tube starting on day +1 post-transplant for at least 7 days, usually until engraftment.

Interventions

  • Enteral Nutrition (Dietary supplement)
    A commercially available blenderized tube feed nutrition (BTF) formula will be initiated at a fixed starting rate of 25 ml/hr. The infusion rate will be increased in consultation with a registered dietitian nutritionist (RDN) based on tolerance to reach a feeding goal of 30-35 kcal/kg/day, which includes 1.5-2 g of protein/kg/day.

Eligibility criteria

Inclusion Criteria: * Diagnosis of a hematological condition or serious blood disorder * Patient planned for an allogeneic hematopoietic stem cell transplant * Any conditioning regimen or graft source Exclusion Criteria: * Uncorrected anatomical deformity of the nose, nasopharynx, esophagus, or stomach that could prevent proper placement of a nasogastric tube. * Chronic gastrointestinal conditions causing malabsorption or need for nutritional supplementation, e.g., celiac disease, short gut syndrome, chronic use of total parental nutrition or enteral nutrition for 3 or more months. Uncorrected anatomical deformity may include any known significant deviated nasal septum, large nasal polyps or other masses, or nasal or oropharyngeal trauma.

Conditions

Allogeneic Hematopoietic Stem Cell Transplant (Allo-HSCT)

Locations

  • Fred & Pamela Buffet Cancer Center — Omaha, Nebraska, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record