Leukemia, Acute Lymphoblastic Clinical Trial
Official title:
Effect of Fish Oil Versus Placebo on Hyperlipidemia and Toxicities in Children and Young Adults With Acute Lymphoblastic Leukemia - A Randomized Controlled 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.
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