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

Rigshospitalet

Status: Enrolling

Conditions: Leukemia, Acute Lymphoblastic

Treatments: Dietary Supplement: Eskimo-3 Pure Fish Oil; Dietary Supplement: Rapeseed Oil

Study type: Interventional

Funder types: Other

Identifiers

NCT04209244

H-19054660

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 1 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• Patients diagnosed with ALL, stratified to high risk (HR) after induction treatment or stem cell transplantation in the ALLTogether protocol

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

Fish oil

Experimental group

Description:

Eskimo-3 Pure Fish Oil, 10 ml per day (2.6 g EPA+DHA)

Treatment:

Dietary Supplement: Eskimo-3 Pure Fish Oil

Placebo

Placebo Comparator group

Description:

Rapeseed Oil, 10 ml per day

Treatment:

Dietary Supplement: Rapeseed Oil