A Phase 2 interventional study of Enteral Nutrition in Allogeneic Hematopoietic Stem Cell Transplant (Allo-HSCT), sponsored by University of Nebraska. Recruiting at 1 site in United States. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-08-31.
Sponsored by University of Nebraska · Phase 2, Interventional, and Supportive care
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.
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).
University of Nebraska is the lead sponsor of 473 studies on the registry; 66 are open to participants now.
Of its 75 completed or terminated interventional studies of FDA-regulated products, 46 (61%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects randomized to the control group with preserved oral intake will initiate conventional oral nutrition as tolerated. The dietary regimen is composed of a balanced general diet. Early supplemental nutrition will not be initiated in patients with the control group who are maintaining adequate oral intake.
Dietary Supplement: Enteral Nutrition
The study group will start blenderized nutrition formula supplementation via enteral feeding tube on day +1 after transplant.
Dietary Supplement: Enteral Nutrition
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.
Incidence of Stage 3-4 Acute GVHD of Lower Gut
Cumulative incidence will be calculated as the time to stage 3-4 acute GVHD of the lower gut for each of the study arms.
Time frame: 100 Days post- transplant
Incidence of Stage 2-4 Acute GVHD of Lower Gut
Cumulative incidence will be calculated as the time to stage 2-4 acute GVHD of the lower gut for each of the study arms
Time frame: 100 Days post- transplant
Percent change in weight
Percent change from baseline weight at day +30 and day +100 post-transplant.
Time frame: Day +30 and Day +100 post-transplant
Percent change in lean body mass
Percent change in total lean body mass measured by DEXA scan at baseline and day +30 post-transplant.
Time frame: Baseline and Day +30 post-transplant
Health-Related Quality of Life (HRQoL)
Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT), total score range 0-148, where higher scores indicate better quality of life.
Time frame: Baseline and Day +100 post-transplant
Transplant hospital stay
Median duration of transplant hospital stay compared between groups.
Time frame: Up to approximately 30 Days Post Transplant
Platelet and neutrophil engraftment
Cumulative incidence curves of platelet engraftment and neutrophil engraftment will be generated using the methods of Gray to adjust for the competing risk of death to determine the probabilities of neutrophil and platelet engraftment.
Time frame: Aproximately14 days post-transplant
Fried Frailty Index score
Fried Frailty Index score ranges from 0 to 5, where higher scores indicate greater frailty (worse functional status).
Time frame: Day +30, and Day +100 post-transplant
Activities of Daily Living (ADL)
Change in Activities of Daily Living (ADL) score from baseline to Day +30 and Day+100 post-transplant. The ADL scale ranges from 0 to 6, where higher scores indicate greater independence (better functional status).
Time frame: Day +30, and Day +100 post-transplant
Instrumental Activities of Daily Living (IADL)
Change in Instrumental Activities of Daily Living (IADL) score from baseline to Day +30 and Day +100 post - transplant. The IADL score ranges from 0 to 8, where higher scores indicate greater independence (better functional status).
Time frame: Day +30, and Day +100 post-transplant
Karnofsky Performance Scale
Karnofsky Performance Scale ranges from 0 to 100, where higher scores indicate better functional status.
Time frame: Day +30, and Day +100 post-transplant
Plan to share: No
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