Effect of Fish Oil on Hyperlipidemia and Toxicities in Children and Young Adults With Acute Lymphoblastic Leukemia
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|ClinicalTrials.gov Identifier: NCT04209244|
Recruitment Status : Recruiting
First Posted : December 24, 2019
Last Update Posted : December 26, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia, Acute Lymphoblastic||Dietary Supplement: Eskimo-3 Pure Fish Oil Dietary Supplement: Rapeseed Oil||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Actual Study Start Date :||December 16, 2019|
|Estimated Primary Completion Date :||July 31, 2023|
|Estimated Study Completion Date :||December 31, 2029|
Experimental: Fish oil
Eskimo-3 Pure Fish Oil, 10 ml per day (2.6 g EPA+DHA)
Dietary Supplement: Eskimo-3 Pure Fish Oil
Dosage: 10 ml/day (2.6 g EPA+DHA)
Other Name: Fish Oil
Placebo Comparator: Placebo
Rapeseed Oil, 10 ml per day
Dietary Supplement: Rapeseed Oil
Dosage: 10 ml/day (0 g EPA+DHA)
Other Name: Placebo
- 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.
- 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.
- 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
- 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.
- 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.
- 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
- 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.
- Milder side effects [ Time Frame: At end of intervention (day 169 or 204) ]Assessed by questionnaire.
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04209244
|Contact: Renate Dagsdottir Laumann, MScemail@example.com|
|Aalborg University Hospital||Not yet recruiting|
|Contact: Steen Rosthøj, MD|
|Aarhus University Hospital||Not yet recruiting|
|Contact: Birgitte Klug Albertsen, MD|
|Copenhagen, Denmark, 2100|
|Contact: Renate Dagsdottir Laumann, MSc +4560163957 firstname.lastname@example.org|
|Odense University Hospital||Not yet recruiting|
|Contact: Peder Skov Wehner, MD|
|Study Chair:||Thomas Leth Frandsen||Rigshospitalet, Denmark|