About this trial
Acute lymphoblastic leukemia (ALL) is the most common malignant disease among children. Treatment results have improved over time due to intensive risk-adapted therapy and the 5-year survival rate is now above 90%. However, the burden of therapy has increased proportionally. Many children develop serious acute and chronic side effects, which impact on the patients expected lifespan and impair their quality of life as a result of therapy. Treatment with PEG-asparaginase and dexamethasone increases the levels of triglycerides and total cholesterol. Consequently, the incidence of hyperlipidemia is high during initial ALL therapy. Studies have suggested that hyperlipidemia is a risk factor for development of osteonecrosis, thrombosis and possibly acute pancreatitis.
Long-chained marine omega-3 fatty acids, found in fish oil, decrease levels of triglycerides and total cholesterol in hyperlipidemic patients. Due to the high survival rate, it is of great interest to develop methods to reduce treatment related toxicities.
The investigators hypothesise that daily intake of fish oil will prevent development of hyperlipidemia during ALL treatment phases with dexamethasone and PEG-asparaginase compared to placebo and that fish oil intake may reduce the incidence of severe adverse events related to ALL treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Patients diagnosed with ALL, stratified to high risk (HR) after induction treatment or stem cell transplantation in the ALLTogether protocol
Trial design
Parallel
Treatments tested in this trial
Eskimo-3 Pure Fish Oil
Dietary supplementDosage: 10 ml/day (2.6 g EPA+DHA)
Rapeseed Oil
Dietary supplementDosage: 10 ml/day (0 g EPA+DHA)
Treatment groups
Trial outcomes
Primary outcomes
Hyperlipidemia
Triglycerides and/or total cholesterol levels five times or more than the age-dependent upper normal limit.
Secondary outcomes
Lipid metabolism
Triglycerides, total cholesterol, VLDL-cholesterol, LDL-cholesterol and HDL-cholesterol.
Compliance
Assessed by self-registration forms, return of bottles and levels of EPA+DHA in whole blood
Bone density
Assessed by DEXA-scan and bone biomarkers (iCa, PTH, vit D, phosphate, magnesium, creatinine, alkaline phosphatase, CTX, P1NP.
Hemostatic status
Thromboelastography (TEG), multiplate and thrombocytes.
Other outcomes
Milder side effects
Assessed by questionnaire.
Dietary intake
Assessed by 3-day food records
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Rigshospitalet, Denmark
Lead sponsor
Danish Child Cancer Foundation
Collaborator