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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
100
Dosage: 10 ml/day (2.6 g EPA+DHA)
Dosage: 10 ml/day (0 g EPA+DHA)
Aalborg University Hospital
Aalborg, Denmark
NOT_YET_RECRUITINGAarhus University Hospital
Aarhus, Denmark
NOT_YET_RECRUITINGRigshospitalet
Copenhagen, Denmark
RECRUITINGOdense University Hospital
Odense, Denmark
NOT_YET_RECRUITINGHyperlipidemia
Triglycerides and/or total cholesterol levels five times or more than the age-dependent upper normal limit.
Time frame: From treatment day 4 until treatment day 169 or 204
Lipid metabolism
Triglycerides, total cholesterol, VLDL-cholesterol, LDL-cholesterol and HDL-cholesterol.
Time frame: VLR and IR-low: 4, 11, 18, 25, 32, 39, 46, 53, 60, 67, 81, 95, 109, 123, 137, 151 and 169. IR-high: treatment day 4, 11, 18, 25, 32, 39, 46, 53, 60, 67, 74, 81, 88, 95, 102, 109, 123, 137, 151, 165, 179, 193 and 204.
Compliance
Assessed by self-registration forms, return of bottles and levels of EPA+DHA in whole blood
Time frame: From treatment day 4 until end of intervention (treatment day 169 or 204)
Bone density
Assessed by DEXA-scan and bone biomarkers (iCa, PTH, vit D, phosphate, magnesium, creatinine, alkaline phosphatase, CTX, P1NP.
Time frame: DEXA-scan at start and end of intervention. Bone biomarkers at treatment day 4, 81 and 169 for VLR and treatment day 4, 102 and 204 for IR-low and IR-high.
Hemostatic status
Thromboelastography (TEG), multiplate and thrombocytes.
Time frame: At treatment day 4, 81 and 169 for VLR and at treatment day 4, 102 and 204 for IR-low and IR-high
Endothelial function
sTM, syndecan-1, PECAM, VEGFR1
Time frame: At treatment day 4, 81 and 169 for VLR and at treatment day 4, 102 and 204 for IR-low and IR-high
Incidence of severe adverse events
Cumulative incidence of osteonecrosis, asparaginase associated pancreatitis and thrombosis.
Time frame: From treatment day 4 until end of intervention (treatment day 169 or 204)
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