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

University of Nebraska

Status and phase

Begins enrollment in 1 month

Phase 2

Conditions

Allogeneic Hematopoietic Stem Cell Transplant (Allo-HSCT)

Treatments

Dietary Supplement: Enteral Nutrition

Study type

Interventional

Funder types

Other

Identifiers

NCT07315165

ENABLE

Details and patient eligibility

About

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).

Enrollment

112 estimated patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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.