Using fish oil to reduce side effects in young patients with leukemia
Official title: Effect of Fish Oil Versus Placebo on Hyperlipidemia and Toxicities in Children and Young Adults With Acute Lymphoblastic Leukemia - A Randomized Controlled Trial
Run by Copenhagen University Hospital, Rigshospitalet · NCT04209244 · Data updated 2026-11-12
This study is testing if fish oil can help reduce high cholesterol and triglyceride levels in children and young adults with leukemia who are undergoing treatment.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 1 Year to 45 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Copenhagen University Hospital, Rigshospitalet Academic / other |
| Locations | 4 sites (Aalborg and 3 other locations) |
| Status | Recruiting |
| Started | December 16, 2019 |
| Main results expected | July 31, 2023 |
| Study ends | December 31, 2029 |
| Registry record updated | December 26, 2019 |
| Trial ID | NCT04209244 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are children and young adults aged 1 to 45 years diagnosed with acute lymphoblastic leukemia and classified as very-low or intermediate risk.
✕Probably not a fit
Patients diagnosed with high-risk acute lymphoblastic leukemia or those who have undergone stem cell transplantation may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the effects of fish oil on hyperlipidemia and treatment-related toxicities in children and young adults diagnosed with acute lymphoblastic leukemia (ALL). Given the high survival rates associated with ALL treatment, the study aims to explore how long-chained marine omega-3 fatty acids can help lower triglyceride and cholesterol levels, which are often elevated due to certain chemotherapy agents. Participants will receive either Eskimo-3 Pure Fish Oil or Rapeseed Oil to assess the impact on their lipid profiles and overall health during treatment. The study includes patients aged 1 to 45 years who are classified as very-low risk or intermediate risk for ALL.
Why it matters
Potential benefit: If successful, this study could significantly improve the quality of life for young patients undergoing treatment for leukemia by reducing harmful side effects.
How similar studies have gone: While the approach of using fish oil for managing hyperlipidemia is established, this specific application in the context of ALL treatment is novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Children (1-17.9 years) and young adults (18-45 years) diagnosed with ALL, stratified to very-low risk (VRL), intermediate risk low (IR-low) and intermediate risk high (IR-high) in the ALLTogether protocol. Exclusion Criteria: * Patients diagnosed with ALL, stratified to high risk (HR) after induction treatment or stem cell transplantation in the ALLTogether protocol
Where it's running
-
Rigshospitalet
Copenhagen, Denmark Recruiting -
Aalborg University Hospital
Aalborg, Denmark Not yet recruiting -
Aarhus University Hospital
Aarhus, Denmark Not yet recruiting -
Odense University Hospital
Odense, Denmark Not yet recruiting
Study contacts
- Study coordinator: Renate Dagsdottir Laumann, MSc
- Email: renate.dagsdottir.laumann@regionh.dk
- Phone: +4560163957
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.