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

NCT07315165 | Not Yet Recruiting Phase 2

• 1 other identifier: ENABLE
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Allogeneic Hematopoietic Stem Cell Transplant (Allo-HSCT)

Keywords

Enteral Nutrition; Acute GVHD; Stage 3-4; Stage 2-4 Gut GVHD; Nutritional Support; allo-HSCT.

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Incidence of Stage 2-4 Acute GVHD of Lower Gut

  100 Days post- transplant

• Percent change in weight

  Day +30 and Day +100 post-transplant

• Percent change in lean body mass

  Baseline and Day +30 post-transplant

• Health-Related Quality of Life (HRQoL)

  Baseline and Day +100 post-transplant

• Transplant hospital stay

  Up to approximately 30 Days Post Transplant

Study Arms (2)

The control (initiation of supplemental enteral or parenteral nutrition as clinically indicated)

ACTIVE COMPARATOR

Dietary Supplement: Enteral Nutrition

The study group (enteral nutrition starting on day +1)

EXPERIMENTAL

Dietary Supplement: Enteral Nutrition

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.

The control (initiation of supplemental enteral or parenteral nutrition as clinically indicated); The study group (enteral nutrition starting on day +1)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

Fred & Pamela Buffet Cancer Center

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Interventions

Enteral Nutrition

Intervention Hierarchy (Ancestors)

Feeding Methods; Therapeutics; Nutritional Support; Nutrition Therapy

Study Officials

• Michael Haddadin, MD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Krishna vamsi Gottipati, MS

CONTACT

(402) 5593518; krgottipati@unmc.edu

IIT Office Clinical Trails Office

CONTACT

(402) 5590963; IITOFFICE@unmc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All patients in both arms will receive nutrition counseling regarding the use of a high-protein, high-energy diet with snacks and high-protein supplement drinks, as tolerated. Two groups will be randomized, one receiving standard of care and the other receiving eteral nutrition via nasogastric tube. Outcomes will be compared between the two groups. In the study group, enteral nutrition will be administered, starting on allo-HSCT day +1 (the day after the infusion of stem cell transplant). Enteral nutrition will be administered through an enteral nutrition tube; the most commonly used equipment is a nasogastric tube of 8-10 Fr gauge.

Study Record Dates

• First Submitted: December 18, 2025
• First Posted: January 2, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): April 1, 2031
• Last Updated: January 8, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)