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

Primary Purpose

Leukemia, Acute Lymphoblastic

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Eskimo-3 Pure Fish Oil
Rapeseed Oil
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Leukemia, Acute Lymphoblastic

Eligibility Criteria

1 Year - 45 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Aalborg University Hospital
  • Aarhus University Hospital
  • RigshospitaletRecruiting
  • Odense University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Fish oil

Placebo

Arm Description

Eskimo-3 Pure Fish Oil, 10 ml per day (2.6 g EPA+DHA)

Rapeseed Oil, 10 ml per day

Outcomes

Primary Outcome Measures

Hyperlipidemia
Triglycerides and/or total cholesterol levels five times or more than the age-dependent upper normal limit.

Secondary Outcome Measures

Lipid metabolism
Triglycerides, total cholesterol, VLDL-cholesterol, LDL-cholesterol and HDL-cholesterol.
Compliance
Assessed by self-registration forms, return of bottles and levels of EPA+DHA in whole blood
Bone density
Assessed by DEXA-scan and bone biomarkers (iCa, PTH, vit D, phosphate, magnesium, creatinine, alkaline phosphatase, CTX, P1NP.
Hemostatic status
Thromboelastography (TEG), multiplate and thrombocytes.
Endothelial function
sTM, syndecan-1, PECAM, VEGFR1
Incidence of severe adverse events
Cumulative incidence of osteonecrosis, asparaginase associated pancreatitis and thrombosis.

Full Information

First Posted
December 19, 2019
Last Updated
December 23, 2019
Sponsor
Rigshospitalet, Denmark
Collaborators
Danish Child Cancer Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04209244
Brief Title
Effect of Fish Oil on Hyperlipidemia and Toxicities in Children and Young Adults With Acute Lymphoblastic Leukemia
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Recruiting
Study Start Date
December 16, 2019 (Actual)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
December 31, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark
Collaborators
Danish Child Cancer Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Acute Lymphoblastic

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fish oil
Arm Type
Experimental
Arm Description
Eskimo-3 Pure Fish Oil, 10 ml per day (2.6 g EPA+DHA)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Rapeseed Oil, 10 ml per day
Intervention Type
Dietary Supplement
Intervention Name(s)
Eskimo-3 Pure Fish Oil
Other Intervention Name(s)
Fish Oil
Intervention Description
Dosage: 10 ml/day (2.6 g EPA+DHA)
Intervention Type
Dietary Supplement
Intervention Name(s)
Rapeseed Oil
Other Intervention Name(s)
Placebo
Intervention Description
Dosage: 10 ml/day (0 g EPA+DHA)
Primary Outcome Measure Information:
Title
Hyperlipidemia
Description
Triglycerides and/or total cholesterol levels five times or more than the age-dependent upper normal limit.
Time Frame
From treatment day 4 until treatment day 169 or 204
Secondary Outcome Measure Information:
Title
Lipid metabolism
Description
Triglycerides, total cholesterol, VLDL-cholesterol, LDL-cholesterol and HDL-cholesterol.
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.
Title
Compliance
Description
Assessed by self-registration forms, return of bottles and levels of EPA+DHA in whole blood
Time Frame
From treatment day 4 until end of intervention (treatment day 169 or 204)
Title
Bone density
Description
Assessed by DEXA-scan and bone biomarkers (iCa, PTH, vit D, phosphate, magnesium, creatinine, alkaline phosphatase, CTX, P1NP.
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.
Title
Hemostatic status
Description
Thromboelastography (TEG), multiplate and thrombocytes.
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
Title
Endothelial function
Description
sTM, syndecan-1, PECAM, VEGFR1
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
Title
Incidence of severe adverse events
Description
Cumulative incidence of osteonecrosis, asparaginase associated pancreatitis and thrombosis.
Time Frame
From treatment day 4 until end of intervention (treatment day 169 or 204)
Other Pre-specified Outcome Measures:
Title
Milder side effects
Description
Assessed by questionnaire.
Time Frame
At end of intervention (day 169 or 204)
Title
Dietary intake
Description
Assessed by 3-day food records
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Renate Dagsdottir Laumann, MSc
Phone
+4560163957
Email
renate.dagsdottir.laumann@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Leth Frandsen
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Study Chair
Facility Information:
Facility Name
Aalborg University Hospital
City
Aalborg
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steen Rosthøj, MD
Facility Name
Aarhus University Hospital
City
Aarhus
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Birgitte Klug Albertsen, MD
Facility Name
Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Renate Dagsdottir Laumann, MSc
Phone
+4560163957
Email
renate.dagsdottir.laumann@regionh.dk
Facility Name
Odense University Hospital
City
Odense
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peder Skov Wehner, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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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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