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Not yet recruiting NCT07315165

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

Phase II Interventional Allogeneic Hematopoietic Stem Cell Transplant (Allo-HSCT)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Enteral Nutrition.
Who it may be relevant to
Registry conditions: Allogeneic Hematopoietic Stem Cell Transplant (Allo-HSCT). Basic parameters: from 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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).

Interventions

  • 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.

Primary outcome measures

  • Incidence of Stage 3-4 Acute GVHD of Lower Gut [Time frame: 100 Days post- transplant]
Secondary outcome measures (10)
  • Incidence of Stage 2-4 Acute GVHD of Lower Gut [Time frame: 100 Days post- transplant]
  • Percent change in weight [Time frame: Day +30 and Day +100 post-transplant]
  • Percent change in lean body mass [Time frame: Baseline and Day +30 post-transplant]
  • Health-Related Quality of Life (HRQoL) [Time frame: Baseline and Day +100 post-transplant]
  • Transplant hospital stay [Time frame: Up to approximately 30 Days Post Transplant]
  • Platelet and neutrophil engraftment [Time frame: Aproximately14 days post-transplant]
  • Functional status and physical performance [Time frame: Day +30, and Day +100 post-transplant]
  • Functional status and physical performance Activities of Daily Living (ADL) [Time frame: Day +30, and Day +100 post-transplant]
  • Functional status and physical performance Instrumental Activities of Daily Living (IADL) [Time frame: Day +30, and Day +100 post-transplant]
  • Functional status and physical performance [Time frame: Day +30, and Day +100 post-transplant]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Fred & Pamela Buffet Cancer Center — Omaha

Identifiers

NCT: NCT07315165 · 213-26-FB

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗