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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: Clinical Trial Phase 2 study, sponsored by University of Nebraska.
NCT07315165 is a Phase 2 study that has not yet begun recruiting, run by University of Nebraska. The registered enrollment target is 112 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (16% lower). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Cumulative incidence will be calculated as the time to stage 3-4 acute GVHD of the lower gut for each of the study arms.
Interventions
- DIETARY_SUPPLEMENT Enteral Nutrition
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 112 participants |
| Start Date | 2026-04 |
| Est. Completion | 2031-04 |
| Phase | Phase 2 |
What is known before NCT07315165 opens enrollment
NCT07315165 is an interventional study that assigns participants to a tested intervention. The registered 112 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (16% lower).
The record links to 0 conditions, and to 1 intervention - of which Enteral Nutrition is the first listed.
NCT07315165 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07315165's enrollment target sits among peer trials
112 631st of 2000 higher than 1,369 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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