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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-45
SponsorRigshospitalet, Denmark

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Eskimo-3 Pure Fish Oil

    Dietary supplement

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

  • Rapeseed Oil

    Dietary supplement

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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Fish oilExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Hyperlipidemia

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

Secondary outcomes

1

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.
2

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)
3

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.
4

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

Other outcomes

1

Milder side effects

Assessed by questionnaire.

Time frame
At end of intervention (day 169 or 204)
2

Dietary intake

Assessed by 3-day food records

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rigshospitalet, Denmark

Lead sponsor

Danish Child Cancer Foundation

Collaborator