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

ConditionAllogeneic Hematopoietic Stem Cell Transplant (Allo-HSCT)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age19+
SponsorUniversity of Nebraska

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of a hematological condition or serious blood disorder

Patient planned for an allogeneic hematopoietic stem cell transplant

Any conditioning regimen or graft source

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

112 Participants
are divided into 2 treatment groups
Group A: The control (initiation of supplemental enteral or parenteral nutrition as clinically indicated)Active comparator 1 intervention
Group B: The study group (enteral nutrition starting on day +1)Experimental treatment 1 intervention

Trial outcomes

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.

Time frame
100 Days post- transplant

Secondary outcomes

1

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

Time frame
100 Days post- transplant
2

Percent change in weight

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

Time frame
Day +30 and Day +100 post-transplant
3

Percent change in lean body mass

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

Time frame
Baseline and Day +30 post-transplant
4

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.

Time frame
Baseline and Day +100 post-transplant

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Nebraska

Lead sponsor

Source ClinicalTrials.gov
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