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

Leukemia, Acute Lymphoblastic Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04209244
• Other study ID #: H-19054660
• Status: Recruiting
• Phase: N/A
• Start date: December 16, 2019
• Est. completion date: December 31, 2029

Study information

• Verified date: December 2019
• Source: Rigshospitalet, Denmark
• Contact: Renate Dagsdottir Laumann, MSc
• Phone: +4560163957
• Email: renate.dagsdottir.laumann[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2029
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Hyperlipidemias
• Hyperlipoproteinemias
• Leukemia
• Leukemia, Acute Lymphoblastic
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

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

Locations

Country	Name	City	State
Denmark	Aalborg University Hospital	Aalborg
Denmark	Aarhus University Hospital	Aarhus
Denmark	Rigshospitalet	Copenhagen
Denmark	Odense University Hospital	Odense

Sponsors (2)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Danish Child Cancer Foundation

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Milder side effects	Assessed by questionnaire.	At end of intervention (day 169 or 204)
Other	Dietary intake	Assessed by 3-day food records	At treatment day 4, 81 and 169 for VLR and at treatment day 4, 102 and 204 for IR-low and IR-high
Primary	Hyperlipidemia	Triglycerides and/or total cholesterol levels five times or more than the age-dependent upper normal limit.	From treatment day 4 until treatment day 169 or 204
Secondary	Lipid metabolism	Triglycerides, total cholesterol, VLDL-cholesterol, LDL-cholesterol and HDL-cholesterol.	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.
Secondary	Compliance	Assessed by self-registration forms, return of bottles and levels of EPA+DHA in whole blood	From treatment day 4 until end of intervention (treatment day 169 or 204)
Secondary	Bone density	Assessed by DEXA-scan and bone biomarkers (iCa, PTH, vit D, phosphate, magnesium, creatinine, alkaline phosphatase, CTX, P1NP.	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.
Secondary	Hemostatic status	Thromboelastography (TEG), multiplate and thrombocytes.	At treatment day 4, 81 and 169 for VLR and at treatment day 4, 102 and 204 for IR-low and IR-high
Secondary	Endothelial function	sTM, syndecan-1, PECAM, VEGFR1	At treatment day 4, 81 and 169 for VLR and at treatment day 4, 102 and 204 for IR-low and IR-high
Secondary	Incidence of severe adverse events	Cumulative incidence of osteonecrosis, asparaginase associated pancreatitis and thrombosis.	From treatment day 4 until end of intervention (treatment day 169 or 204)