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

Not Applicable

Recruiting

• Conditions: Leukemia, Acute Lymphoblastic
• Interventions: Dietary Supplement: Eskimo-3 Pure Fish Oil; Dietary Supplement: Rapeseed Oil

• Registration Number: NCT04209244
• Lead Sponsor: Rigshospitalet, Denmark

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-12
• Study Start: 2019-12-16
• Study First Submitted: 2019-12-19
• Study First Submitted QC: 2019-12-19
• Last Update Submitted: 2019-12-23
• Study First Posted: 2019-12-24
• Last Update Posted: 2019-12-26
• Primary Completion: 2023-07-31
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fish oil	Eskimo-3 Pure Fish Oil	Eskimo-3 Pure Fish Oil, 10 ml per day (2.6 g EPA+DHA)
Placebo	Rapeseed Oil	Rapeseed Oil, 10 ml per day

Primary Outcome Measures

Name	Time	Method
Hyperlipidemia	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 Outcome Measures

Name	Time	Method
Compliance	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
Lipid metabolism	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.
Bone density	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.
Hemostatic status	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.
Endothelial function	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
Incidence of severe adverse events	From treatment day 4 until end of intervention (treatment day 169 or 204)	Cumulative incidence of osteonecrosis, asparaginase associated pancreatitis and thrombosis.

Trial Locations

Locations (4)

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark

Rigshospitalet; 🇩🇰 Copenhagen, Denmark

Aalborg University Hospital; 🇩🇰 Aalborg, Denmark

Odense University Hospital; 🇩🇰 Odense, Denmark