Fish oil may help kids survive stem cell transplants with fewer side effects
NCT ID NCT02512718
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This early-stage trial tested whether a fish oil fat emulsion is safe for children undergoing stem cell transplants for cancer or blood disorders. Twenty children received either fish oil or standard soybean oil fat emulsion through an IV. The goal was to see if fish oil could reduce infections and other complications, but this small study only looked at safety, not effectiveness.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- fish oil lipid emulsion (Omegaven)
- What this could lead to
- If safe, this could pave the way for a larger study to see if fish oil reduces infections and side effects in children after stem cell transplants.
- What could go wrong
- This is a very early, small Phase 1 safety trial with only 20 children. It is not designed to prove effectiveness, and results may not lead to any change in care.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
20 people
The number who actually took part.
- Started
-
Jun 2016
- Finished
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May 2023
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
2 to 18 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion: 1. Planned myeloablative allogeneic bone marrow, cord, or peripheral blood stem cell (from any donor, including haploidentical donor) HCT conditioning regimen using either TBI (planned cumulative dose \>1100cGy) or busulfan in addition to other chemotherapeutic agents 2. Planned related or unrelated bone marrow donor matched at a minimum of out of 10 human leukocyte antigen (HLA) loci (HLA-A, -B, -C, -DRB1, and -DQ), or planned related or unrelated cord blood donor matched at a minimum of 4 out of 6 HLA loci (HLA-A, -B, and -DRB1), or a haplo- identical related donor; typing must be at the allele level for unrelated donors, antigen level typing is acceptable for related donors 3. Diagnosis of a hematological malignancy including myelodysplasia. Exclusion: 1. Unable or unwilling to return for day +30 or day +100 testing 2. GVHD prophylaxis that includes rapamycin 3. Allergy to egg, fish (including seafood and/or shellfish), or soy/legume products a. Patients with egg, fish (including seafood and/or shellfish), or soy/legume intolerance without a documented allergy may still be included at the discretion of the PI and patient/family 4. Other contraindication to PN or intravenous lipids 5. Unstable diabetes mellitus 6. Stroke, cardiac infarction or embolism within 6 months prior to HCT OR current, ongoing treatment for stroke, infarction, and/or embolism 7. Undefined coma status, 8. Lipid nephrosis, 9. Pathological hyperlipidemia (2 consecutive fasting triglyceride levels \> 500 mg/dL), 10. Active/acute pancreatitis with hyperlipidemia (fasting triglyceride levels \> 500 mg/dL) (see section 3.5 for specific diagnostic criteria), 11. History of parenteral nutrition (PN) use with any intravenous lipid product or use of any intravenous lipid product without PN within 6 months prior to HCT 12. Co-enrollment in other interventional clinical studies. 13. Clinically significant pleural or pericardial effusion a) If a pleural or pericardial effusion is noted on the pre-transplant testing echocardiogram, the PI will contact the cardiologist to ask if it is clinically significant. If clinically insignificant pleural or pericardial effusion exists at baseline AND the patient is randomized to FOLE, the PI will seek approval for inclusion with the primary attending and decide upon appropriate monitoring to include close clinical observation, cardiology consultation and/or serial echocardiograms where appropriate. 14. Aluminum toxicity, especially in patients with renal impairment 15. Risk of infection 16. Refeeding syndrome
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Boston Children's Hospital
Boston, Massachusetts, 02115, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can we predict lung damage from CAR t-cell therapy?
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