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NCT Number: NCT07315165

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

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).

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Key information

Conditions

Allogeneic Hematopoietic Stem Cell Transplant (Allo-HSCT)

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Incidence of Stage 3-4 Acute GVHD of Lower Gut

    Time frame: 100 Days post- transplant

    Cumulative incidence will be calculated as the time to stage 3-4 acute GVHD of the lower gut for each of the study arms.

Secondary outcomes

  1. Incidence of Stage 2-4 Acute GVHD of Lower Gut

    Time frame: 100 Days post- transplant

    Cumulative incidence will be calculated as the time to stage 2-4 acute GVHD of the lower gut for each of the study arms

  2. Percent change in weight

    Time frame: Day +30 and Day +100 post-transplant

    Percent change from baseline weight at day +30 and day +100 post-transplant.

  3. Percent change in lean body mass

    Time frame: Baseline and Day +30 post-transplant

    Percent change in total lean body mass measured by DEXA scan at baseline and day +30 post-transplant.

  4. Health-Related Quality of Life (HRQoL)

    Time frame: Baseline and Day +100 post-transplant

    Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT), total score range 0-148, where higher scores indicate better quality of life.

  5. Transplant hospital stay

    Time frame: Up to approximately 30 Days Post Transplant

    Median duration of transplant hospital stay compared between groups.

  6. Platelet and neutrophil engraftment

    Time frame: Aproximately14 days post-transplant

    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.

  7. Functional status and physical performance

    Time frame: Day +30, and Day +100 post-transplant

    Fried Frailty Index score ranges from 0 to 5, where higher scores indicate greater frailty (worse functional status).

  8. Functional status and physical performance Activities of Daily Living (ADL)

    Time frame: Day +30, and Day +100 post-transplant

    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).

  9. Functional status and physical performance Instrumental Activities of Daily Living (IADL)

    Time frame: Day +30, and Day +100 post-transplant

    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).

  10. Functional status and physical performance

    Time frame: Day +30, and Day +100 post-transplant

    Karnofsky Performance Scale ranges from 0 to 100, where higher scores indicate better functional status.

Study contacts

Contact information is provided by the study sponsor or research team.

IIT Office Clinical Trails Office

CONTACT

[email protected]

(402) 5590963

Krishna vamsi Gottipati, MS

CONTACT

[email protected]

(402) 5593518

Sponsors and collaborators

Lead sponsor

University of Nebraska

Other

Registry information

Official study title

A Phase II Randomized Trial of Enteral Nutrition Versus Standard of Care in Allogeneic Hematopoietic Stem Cell Transplantation

Important dates

Study start
2026
Primary completion
2030
Study completion
2031
First posted
Jan 2, 2026
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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