A Phase II Randomized Trial of Enteral Nutrition Versus Standard of Care in Allogeneic Hematopoietic Stem Cell Transplantation
Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:
• Diagnosis of a hematological condition or serious blood disorder
• Patient planned for an allogeneic hematopoietic stem cell transplant
• Any conditioning regimen or graft source
Locations
United States
Nebraska
Fred & Pamela Buffet Cancer Center
RECRUITING
Omaha
Contact Information
Primary
Krishna vamsi Gottipati, MS
krgottipati@unmc.edu
(402) 5593518
Backup
IIT Office Clinical Trails Office
IITOFFICE@unmc.edu
(402) 5590963
Time Frame
Start Date: 2026-07-22
Estimated Completion Date: 2031-05
Participants
Target number of participants: 112
Treatments
Active_comparator: The control (initiation of supplemental enteral or parenteral nutrition as clinically indicated)
Subjects randomized to the control group with preserved oral intake will initiate conventional oral nutrition as tolerated. The dietary regimen is composed of a balanced general diet. Early supplemental nutrition will not be initiated in patients with the control group who are maintaining adequate oral intake.
Experimental: The study group (enteral nutrition starting on day +1)
The study group will start blenderized nutrition formula supplementation via enteral feeding tube on day +1 after transplant.
Related Therapeutic Areas
Sponsors
Leads: University of Nebraska