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Recruiting NCT04209244

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

No phase Interventional Leukemia, Acute Lymphoblastic

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Eskimo-3 Pure Fish Oil, Rapeseed Oil.
Who it may be relevant to
Registry conditions: Leukemia, Acute Lymphoblastic. Basic parameters: 1 year — 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

Interventions

  • Dietary supplement Eskimo-3 Pure Fish Oil
    Dosage: 10 ml/day (2.6 g EPA+DHA)
  • Dietary supplement Rapeseed Oil
    Dosage: 10 ml/day (0 g EPA+DHA)

Primary outcome measures

  • Hyperlipidemia [Time frame: From treatment day 4 until treatment day 169 or 204]
Secondary outcome measures (6)
  • 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.]
  • Compliance [Time frame: From treatment day 4 until end of intervention (treatment day 169 or 204)]
  • 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.]
  • 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]
  • 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]
  • Incidence of severe adverse events [Time frame: From treatment day 4 until end of intervention (treatment day 169 or 204)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Prevention

Study locations

Denmark · 4 centers
  • Aalborg University Hospital — Aalborg
  • Aarhus University Hospital — Aarhus
  • Rigshospitalet — Copenhagen
  • Odense University Hospital — Odense

Identifiers

NCT: NCT04209244 · H-19054660

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗