Actively Recruiting
Effect of Fish Oil Versus Placebo on Hyperlipidemia and Toxicities in Children and Young Adults With Acute Lymphoblastic Leukemia - A Randomized Controlled Trial
Led by Rigshospitalet, Denmark · Updated on 2019-12-26
100
Participants Needed
4
Research Sites
335 weeks
Total Duration
On this page
Sponsors
R
Rigshospitalet, Denmark
Lead Sponsor
D
Danish Child Cancer Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Acute lymphoblastic leukemia (ALL) is the most common cancer in children, with improved survival rates now above 90% due to intensive, risk-adapted treatments. However, these treatments often cause serious side effects affecting lifespan and quality of life. This trial studies whether daily fish oil intake can prevent hyperlipidemia, a common side effect caused by ALL treatments such as PEG-asparaginase and dexamethasone, which may lead to other severe conditions like osteonecrosis, thrombosis, and pancreatitis. Participants will be randomly assigned to receive either Eskimo-3 Pure Fish Oil (10 ml per day providing 2.6 g EPA+DHA) or a placebo of rapeseed oil (10 ml per day) during specific ALL treatment phases involving dexamethasone and PEG-asparaginase. The study compares the effect of fish oil versus placebo on lipid levels and treatment-related toxicities over treatment days 4 to 169 or 204, depending on risk stratification. During the study, participants will have multiple assessments including lipid metabolism checks, bone density scans using DEXA at start and end, and evaluations of hemostatic status and endothelial function at various treatment days. Compliance with the intervention and incidence of severe adverse events will be monitored throughout. The total participation duration covers the initial treatment phases with detailed follow-up visits to measure these outcomes and safety.
CONDITIONS
Brief Title
Effect of Fish Oil on Hyperlipidemia and Toxicities in Children and Young Adults With Acute Lymphoblastic Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 1 to 17.9 years and young adults aged 18 to 45 years diagnosed with acute lymphoblastic leukemia (ALL)
- Classified as very-low risk, intermediate risk low, or intermediate risk high under the ALLTogether protocol
You will not qualify if you...
- Patients classified as high risk after induction treatment
- Patients who have undergone stem cell transplantation under the ALLTogether protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From treatment day 4 until treatment day 169 or 204
Participants take either fish oil or placebo daily to assess effects on hyperlipidemia and toxicities during leukemia treatment.
Multiple visits on treatment days 4, 11, 18, 25, 32, 39, 46, 53, 60, 67, 74, 81, 88, 95, 102, 109, 123, 137, 151, 165, 169, 179, 193 and 204 depending on risk group
Trial Site Locations
Total: 4 locations
1
Aalborg University Hospital
Aalborg, Denmark
Not Yet Recruiting
2
Aarhus University Hospital
Aarhus, Denmark
Not Yet Recruiting
3
Rigshospitalet
Copenhagen, Denmark, 2100
Actively Recruiting
4
Odense University Hospital
Odense, Denmark
Not Yet Recruiting
Research Team
R
Renate Dagsdottir Laumann, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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