RecruitingNot ApplicableNCT04209244

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

Effect of Fish Oil Versus Placebo on Hyperlipidemia and Toxicities in Children and Young Adults With Acute Lymphoblastic Leukemia - A Randomized Controlled Trial


Sponsor

Rigshospitalet, Denmark

Enrollment

100 participants

Start Date

Dec 16, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 1 YearMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This study is examining whether fish oil supplements can help reduce high cholesterol and decrease the side effects of chemotherapy in children and young adults being treated for acute lymphoblastic leukemia (ALL). **You may be eligible if...** - You are between 1 and 45 years old - You have been diagnosed with acute lymphoblastic leukemia (ALL) - You have been classified as very low risk, intermediate-low risk, or intermediate-high risk under the ALLTogether treatment protocol **You may NOT be eligible if...** - Your ALL has been classified as high risk after initial treatment - You have undergone a stem cell transplant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTEskimo-3 Pure Fish Oil

Dosage: 10 ml/day (2.6 g EPA+DHA)

DIETARY_SUPPLEMENTRapeseed Oil

Dosage: 10 ml/day (0 g EPA+DHA)


Locations(4)

Aalborg University Hospital

Aalborg, Denmark

Aarhus University Hospital

Aarhus, Denmark

Rigshospitalet

Copenhagen, Denmark

Odense University Hospital

Odense, Denmark

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NCT04209244


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