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

Starting soon · Phase 2

Conditions studied: Allogeneic Hematopoietic Stem Cell Transplant (Allo-HSCT)

In brief

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. The primary endpoint will be cumulative incidence of stage 3-4 acute GVHD of the lower gut by day +100 post-transplant, whereas secondary endpoints will be stage 2-4 acute GVHD of the lower gut by day +100, grade 2-4 acute GVHD, weight loss and changes in lean muscle mass, changes in physical function, health-related quality of life, length of transplant hospital stay, and time to platelet and neutrophil engraftment. Assessments will include acute GVHD assessments and grading, Activities of Daily Living (ADL), Instrumental Activities of Daily Living (IADL), Fried Frailty Index, and Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT).

Key facts

Study ID

NCT07315165

Run by

University of Nebraska

People needed

112

Starts

2026-07-03

Expected to finish

2031-04-01

Last updated by the study team

2026-07-24

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of a hematological condition or serious blood disorder
• Patient planned for an allogeneic hematopoietic stem cell transplant
• Any conditioning regimen or graft source

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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