Effects of Omega-3 Fatty Acids on Acute Graft-versus-Host Disease After Allogeneic Stem Cell Transplantation.

NCT07162688 | Enrolling By Invitation Phase 1

• 2 other identifiers: Omega3-aGVHD-01In-hospital project fund
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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 Study Type: Open-label, randomized, single-center proof-of-concept clinical trial Objective: To evaluate the immunomodulatory and metabolic effects of Omega-3 polyunsaturated fatty acids (PUFAs) in patients undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT), and to explore their potential in preventing and mitigating acute graft-versus-host disease (aGVHD). Study Population: More than 30 patients aged 18-65 years undergoing allo-HSCT. Intervention: Daily intravenous infusion of Omega-3 lipid emulsion at 2 mL/kg (equivalent to 0.2 g/kg of fish oil), administered in combination with medium/long-chain fat emulsion, starting from the conditioning regimen until neutrophil and platelet engraftment or up to Day +35. Primary Endpoint: Incidence and severity of aGVHD within 100 days post-transplant. Secondary Endpoints: Immune reconstitution (changes in T, B, and NK cell subsets) Lipid and metabolic regulation (TC, TG, HDL-C, LDL-C, TBA) Incidence and severity of infections Overall survival (OS) and progression-free survival (PFS) Statistical Analysis: Chi-square/Fisher's exact test, Kaplan-Meier survival analysis with log-rank test, multivariate regression, metabolomics and transcriptomics (PCA, PLS-DA), and pathway enrichment and correlation analyses. Expected Outcome: Omega-3 supplementation is expected to reduce the incidence and severity of aGVHD by modulating immune responses and metabolic processes, thereby providing a novel preventive strategy for post-transplant complications.

Conditions

Graft-Versus-Host Disease(GVHD)

Keywords

Allogeneic Hematopoietic Stem Cell Transplantation; Acute Graft-versus-Host Disease; Immunomodulation

Outcome Measures

Primary Outcomes (1)

• Incidence and Severity of Acute Graft-versus-Host Disease (aGVHD) Within 100 Days After Allogeneic Hematopoietic Stem Cell Transplantation

  The primary outcome is to assess the incidence and clinical severity of acute graft-versus-host disease (aGVHD) occurring within 100 days following allogeneic hematopoietic stem cell transplantation. aGVHD will be diagnosed and graded based on standard clinical criteria involving skin, liver, and gastrointestinal tract involvement, using established staging and grading systems.

  Within 100 days post-transplantation

Secondary Outcomes (1)

• Progression-Free Survival (PFS) at Day 100 Post-Transplantation

  100 days post-transplantation

Study Arms (2)

Omega-3 Lipid Emulsion Group

EXPERIMENTAL

Participants in this arm will receive standard post-transplant care plus intravenous Omega-3 lipid emulsion at a dose of 2 mL/kg/day (equivalent to 0.2 g/kg of fish oil). The infusion will begin during the conditioning phase and continue daily until neutrophil and platelet engraftment or up to Day +35 post-transplantation.

Drug: Omega-3 Lipid Emulsion

No Intervention

NO INTERVENTION

Participants in this arm will receive standard post-transplant care as per institutional protocol. No Omega-3 lipid emulsion or additional investigational product will be administered. This group serves as the control group for evaluating the effects of Omega-3 supplementation in the experimental arm.

Interventions

Omega-3 Lipid Emulsion DRUG

Intravenous Omega-3 lipid emulsion administered at a dose of 2 mL/kg/day (equivalent to 0.2 g/kg of fish oil), starting from the conditioning phase prior to hematopoietic stem cell infusion and continuing daily until neutrophil and platelet engraftment or up to Day +35 post-transplantation. The emulsion is infused over 4-6 hours and combined with medium- and long-chain triglyceride emulsion as part of parenteral nutrition.

Also known as: ω-3 Lipid Emulsion, Omega-3 PUFA, Omega-3 Fatty Acid Emulsion

Omega-3 Lipid Emulsion Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fujian Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 353000, China

Location

MeSH Terms

Conditions

Graft vs Host Disease

Interventions

Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Officials

• Ting Yang, MD, PhD

  First Affiliated Hospital of Fujian Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label trial. No participants, care providers, investigators, or outcome assessors are masked to group assignments.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The First Affiliated Hospital of Fujian Medical University

Model Details: This is a single-center, open-label, randomized, parallel assignment trial. Participants undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT) will be randomly assigned in a 1:1 ratio to either receive standard care or standard care plus intravenous Omega-3 lipid emulsion. The intervention will continue until hematopoietic engraftment or up to Day +35 post-transplantation. The primary objective is to assess the effect of Omega-3 supplementation on the incidence and severity of acute graft-versus-host disease (aGVHD) within 100 days post-transplant.

Study Record Dates

• First Submitted: May 26, 2025
• First Posted: September 9, 2025
• Study Start: May 16, 2025
• Primary Completion (Estimated): March 7, 2028
• Study Completion (Estimated): June 15, 2028
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)