Study of Fish Oil to Reduce High Blood Fat Levels and Side Effects in Children and Young Adults With Acute Lymphoblastic Leukemia

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 EPADHA 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.

Effect of Fish Oil on Hyperlipidemia and Toxicities in Children and Young Adults With Acute Lymphoblastic Leukemia