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NCT07315165 · ClinicalTrials.gov registry record · Phase 2
Enteral Nutrition Versus Standard of Care in Allogeneic Hematopoietic Stem Cell Transplantation
A Phase 2 study, sponsored by University of Nebraska.
- Not yet
- Registry status
- Phase 2
- Development phase
- 112
- Enrollment target
NCT07315165 is a Phase 2 study that has not yet begun recruiting, run by University of Nebraska. The registered enrollment target is 112 participants.
The verdict
NCT07315165, a Phase 2 study, has not yet begun recruiting, sponsored by University of Nebraska.
- NOT YET RECRUITING
- Registry status
- Phase 2
- Development phase
- 112 participants
- Enrollment target
Study 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).
Interventions
- DIETARY_SUPPLEMENT Enteral Nutrition
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 112 participants |
| Start Date | 2026-04 |
| Est. Completion | 2031-04 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07315165
The ClinicalTrials.gov registry entry for NCT07315165 describes a study currently listed as not yet recruiting, categorized as Phase 2. The registered enrollment target is 112 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Nebraska, which has 407 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Enteral Nutrition is the first listed.
NCT07315165 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07315165 about?
NCT07315165 is a clinical study titled "Enteral Nutrition Versus Standard of Care in Allogeneic Hematopoietic Stem Cell Transplantation". 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 rec...
What is the current status of trial NCT07315165?
This trial is currently not yet recruiting. It is a Phase 2 study. The enrollment target is 112 participants. The study started on 2026-04. Estimated completion is 2031-04.
What interventions are being tested in trial NCT07315165?
The interventions under investigation include: Enteral Nutrition (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT07315165?
This trial is sponsored by University of Nebraska, which has 407 total clinical trials registered on ClinicalTrials.gov.
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