Status:
ENROLLING_BY_INVITATION
Effects of Omega-3 Fatty Acids on Acute Graft-versus-Host Disease After Allogeneic Stem Cell Transplantation.
Lead Sponsor:
Fujian Medical University
Conditions:
Graft-Versus-Host Disease(GVHD)
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
Study Title: A Study on the Effects and Mechanisms of Omega-3 Polyunsaturated Fatty Acids on Acute Graft-Versus-Host Disease (aGVHD) Following Allogeneic Hematopoietic Stem Cell Transplantation Stud...
Detailed Description
This study evaluates the therapeutic potential of Omega-3 polyunsaturated fatty acids (PUFAs) in the context of acute graft-versus-host disease (aGVHD) following allogeneic hematopoietic stem cell tra...
Eligibility Criteria
Inclusion
- Patients undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT)
- Age 18 to 65 years (inclusive)
- Male or female
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3
- Expected survival of at least 100 days
- Willingness to participate and provide written informed consent
Exclusion
- History of solid organ transplantation
- Serum triglycerides ≥ 7.9 mmol/L
- Uncontrolled diabetes
- Severe dyslipidemia (e.g., LDL-C ≥ 4.9 mmol/L)
- Contraindications to parenteral nutrition (e.g., severe electrolyte imbalance, acidosis)
- Severe hepatic impairment (AST/ALT \> 3× ULN)
- Creatinine clearance \< 15 mL/min
- Known allergy to Omega-3, fish, or egg protein
- Significant psychiatric illness or substance abuse interfering with study compliance
- Participation in another clinical trial or receipt of other experimental treatments during the study
Key Trial Info
Start Date :
May 16 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 15 2028
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT07162688
Start Date
May 16 2025
End Date
June 15 2028
Last Update
November 18 2025
Active Locations (1)
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1
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China, 353000