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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
Sponsor:
Collaborator:
Danish Child Cancer Foundation
Information provided by (Responsible Party):
Renate Dagsdottir Laumann, 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.


Condition or disease Intervention/treatment Phase
Leukemia, Acute Lymphoblastic Dietary Supplement: Eskimo-3 Pure Fish Oil Dietary Supplement: Rapeseed Oil Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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


Arm Intervention/treatment
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




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



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Ages Eligible for Study:   1 Year to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04209244


Contacts
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Contact: Renate Dagsdottir Laumann, MSc +4560163957 renate.dagsdottir.laumann@regionh.dk

Locations
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Denmark
Aalborg University Hospital Not yet recruiting
Aalborg, Denmark
Contact: Steen Rosthøj, MD         
Aarhus University Hospital Not yet recruiting
Aarhus, Denmark
Contact: Birgitte Klug Albertsen, MD         
Rigshospitalet Recruiting
Copenhagen, Denmark, 2100
Contact: Renate Dagsdottir Laumann, MSc    +4560163957    renate.dagsdottir.laumann@regionh.dk   
Odense University Hospital Not yet recruiting
Odense, Denmark
Contact: Peder Skov Wehner, MD         
Sponsors and Collaborators
Rigshospitalet, Denmark
Danish Child Cancer Foundation
Investigators
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Study Chair: Thomas Leth Frandsen Rigshospitalet, Denmark
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Responsible Party: Renate Dagsdottir Laumann, Principal Investigator, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT04209244    
Other Study ID Numbers: H-19054660
First Posted: December 24, 2019    Key Record Dates
Last Update Posted: December 26, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Hyperlipidemias
Hyperlipoproteinemias
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases