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

Conditions

• Allogeneic Hematopoietic Stem Cell Transplant (Allo-HSCT)

Eligibility Criteria

Sex

ALL

Age

19 Years - N/A

Healthy Volunteers

Not accepted

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.

Study Details

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.

Key Dates

First listed

Jan 2, 2026

Start date

Jul 22, 2026

Status verified

Dec 2025

Primary completion

Oct 31, 2030

Completion

May 31, 2031

Study Design

Enrollment

112 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Arms

• Active Comparator: The control (initiation of supplemental enteral or parenteral nutrition as clinically indicated)
  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.
• Experimental: The study group (enteral nutrition starting on day +1)
  The study group will start blenderized nutrition formula supplementation via enteral feeding tube on day +1 after transplant.

Primary Outcome Measure

Incidence of Stage 3-4 Acute GVHD of Lower Gut [ Time Frame: 100 Days post- transplant ]

Central Contacts

• Krishna vamsi Gottipati, MS
  (402) 5593518
  [email protected]
• IIT Office Clinical Trails Office
  (402) 5590963
  [email protected]

Locations (1)

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