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NCT Number: NCT04209244

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

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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Key information

Conditions

Leukemia, Acute Lymphoblastic Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

1 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aalborg University Hospital, Aalborg, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Eskimo-3 Pure Fish Oil

Dietary Supplement

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

Other names: Fish Oil

Rapeseed oil

Dietary Supplement

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

Other names: Placebo

Primary outcomes

  1. Hyperlipidemia

    Time frame: From treatment day 4 until treatment day 169 or 204

    Triglycerides and/or total cholesterol levels five times or more than the age-dependent upper normal limit.

Secondary outcomes

  1. Lipid metabolism

    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.

    Triglycerides, total cholesterol, VLDL-cholesterol, LDL-cholesterol and HDL-cholesterol.

  2. Compliance

    Time frame: From treatment day 4 until end of intervention (treatment day 169 or 204)

    Assessed by self-registration forms, return of bottles and levels of EPA+DHA in whole blood

  3. Bone density

    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.

    Assessed by DEXA-scan and bone biomarkers (iCa, PTH, vit D, phosphate, magnesium, creatinine, alkaline phosphatase, CTX, P1NP.

  4. Hemostatic status

    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

    Thromboelastography (TEG), multiplate and thrombocytes.

  5. Endothelial function

    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

    sTM, syndecan-1, PECAM, VEGFR1

  6. Incidence of severe adverse events

    Time frame: From treatment day 4 until end of intervention (treatment day 169 or 204)

    Cumulative incidence of osteonecrosis, asparaginase associated pancreatitis and thrombosis.

Other outcomes

  1. Milder side effects

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

    Assessed by questionnaire.

  2. Dietary intake

    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

    Assessed by 3-day food records

Study contacts

Contact information is provided by the study sponsor or research team.

Renate Dagsdottir Laumann, MSc

CONTACT

[email protected]

+4560163957

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • Danish Child Cancer Foundation

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2023
Study completion
2029
First posted
Dec 24, 2019
Registry last updated
Dec 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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