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

A Phase II Randomized Trial of 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).

Study Overview

• Status: Not yet recruiting
• Conditions: Allogeneic Hematopoietic Stem Cell Transplant (Allo-HSCT)
• Intervention / Treatment: Dietary supplement: Enteral Nutrition

• Study Type: Interventional
• Enrollment (Estimated): 112
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Krishna vamsi Gottipati, MS; Phone Number: (402) 5593518; Email: krgottipati@unmc.edu
• Study Contact Backup: Name: IIT Office Clinical Trails Office; Phone Number: (402) 5590963; Email: IITOFFICE@unmc.edu

Study Locations

• United States
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • Fred & Pamela Buffet Cancer Center
      • Contact: Michael Haddadin, MD; Phone Number: (402) 5593848; Email: mihaddadin@unmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: The control (initiation of supplemental enteral or parenteral nutrition as clinically indicated)	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.
Experimental: The study group (enteral nutrition starting on day +1)	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	100 Days post- transplant

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	100 Days post- transplant
Percent change in weight	Percent change from baseline weight at day +30 and day +100 post-transplant.	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.	Baseline and Day +30 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.	Aproximately14 days 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.	Baseline and Day +100 post-transplant
Transplant hospital stay	Median duration of transplant hospital stay compared between groups.	Up to approximately 30 Days Post Transplant
Functional status and physical performance	Fried Frailty Index score ranges from 0 to 5, where higher scores indicate greater frailty (worse functional status).	Day +30, and Day +100 post-transplant
Functional status and physical performance 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).	Day +30, and Day +100 post-transplant
Functional status and physical performance 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).	Day +30, and Day +100 post-transplant
Functional status and physical performance	Karnofsky Performance Scale ranges from 0 to 100, where higher scores indicate better functional status.	Day +30, and Day +100 post-transplant

Collaborators and Investigators

• Sponsor: University of Nebraska
• Investigators: Principal Investigator: Michael Haddadin, MD, University of Nebraska

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): April 1, 2031

Study Registration Dates

• First Submitted: December 18, 2025
• First Submitted That Met QC Criteria: December 18, 2025
• First Posted (Estimated): January 2, 2026

Study Record Updates

• Last Update Posted (Actual): January 8, 2026
• Last Update Submitted That Met QC Criteria: January 6, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Enteral Nutrition; Acute GVHD; Stage 3-4; Stage 2-4 Gut GVHD; Nutritional Support; allo-HSCT.
• Additional Relevant MeSH Terms: Therapeutics; Nutrition Therapy; Feeding Methods; Nutritional Support; Enteral Nutrition
• Other Study ID Numbers: ENABLE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No