Using fish oil to reduce side effects in young patients with leukemia
Effect of Fish Oil Versus Placebo on Hyperlipidemia and Toxicities in Children and Young Adults With Acute Lymphoblastic Leukemia - A Randomized Controlled Trial
NA · Rigshospitalet, Denmark · NCT04209244
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 1 Year to 45 Years |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark (other) |
| Locations | 4 sites (Aalborg and 3 other locations) |
| Trial ID | NCT04209244 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Aalborg and 3 other locations
- Aalborg University Hospital — Aalborg, Denmark (NOT_YET_RECRUITING)
- Aarhus University Hospital — Aarhus, Denmark (NOT_YET_RECRUITING)
- Rigshospitalet — Copenhagen, Denmark (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Leukemia, Acute Lymphoblastic