Leukemia, Acute LymphoblasticNCT04209244
Effect of Fish Oil on Hyperlipidemia and Toxicities in Children and Young Adults With Acute Lymphoblastic Leukemia
A study testing Eskimo-3 Pure Fish Oil and Rapeseed Oil in people with Leukemia, Acute Lymphoblastic, run by Copenhagen University Hospital, Rigshospitalet at 4 sites in Denmark.
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. Read more about this study
- Who is it for?
- Ages 1 year to 45 years
- Conditions the study is for
- Leukemia, Acute Lymphoblastic
- What is being tested?
- Eskimo-3 Pure Fish Oil and Rapeseed Oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 4 sitesDenmark
- Study dates
- 16 Dec 2019to 31 Dec 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Patients diagnosed with ALL, stratified to high risk (HR) after induction treatment or stem cell transplantation in the ALLTogether protocol
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark4 sites, 4 recruiting
- Not yet recruiting
Aalborg University Hospital
Aalborg
Steen Rosthøj, MD
- Not yet recruiting
Aarhus University Hospital
Aarhus
Birgitte Klug Albertsen, MD
- Recruiting
Rigshospitalet
Copenhagen, 2100
Renate Dagsdottir Laumann, MSc, +4560163957, renate.dagsdottir.laumann@regionh.dk
- Not yet recruiting
Odense University Hospital
Odense
Peder Skov Wehner, MD
About this study
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
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.
- Conditions
- Leukemia, Acute Lymphoblastic
- Being tested
- Eskimo-3 Pure Fish Oil, Rapeseed Oil
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eskimo-3 Pure Fish OilDietary supplement
Also called Fish Oil
Dosage: 10 ml/day (2.6 g EPA+DHA)
Rapeseed OilDietary supplement
Also called Placebo
Dosage: 10 ml/day (0 g EPA+DHA)
| Study group | Role | What they receive |
|---|---|---|
| Fish oil | Experimental | Eskimo-3 Pure Fish Oil, 10 ml per day (2.6 g EPA+DHA) Receives: Dietary Supplement: Eskimo-3 Pure Fish Oil |
| Placebo | Placebo comparator | Rapeseed Oil, 10 ml per day Receives: Dietary Supplement: Rapeseed Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hyperlipidemia
Triglycerides and/or total cholesterol levels five times or more than the age-dependent upper normal limit.
Measured: From treatment day 4 until treatment day 169 or 204
Secondary outcomes (6)
Lipid metabolism
Triglycerides, total cholesterol, VLDL-cholesterol, LDL-cholesterol and HDL-cholesterol.
Measured: 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.
Compliance
Assessed by self-registration forms, return of bottles and levels of EPA+DHA in whole blood
Measured: From treatment day 4 until end of intervention (treatment day 169 or 204)
Bone density
Assessed by DEXA-scan and bone biomarkers (iCa, PTH, vit D, phosphate, magnesium, creatinine, alkaline phosphatase, CTX, P1NP.
Measured: 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.
Hemostatic status
Thromboelastography (TEG), multiplate and thrombocytes.
Measured: At treatment day 4, 81 and 169 for VLR and at treatment day 4, 102 and 204 for IR-low and IR-high
Endothelial function
sTM, syndecan-1, PECAM, VEGFR1
Measured: At treatment day 4, 81 and 169 for VLR and at treatment day 4, 102 and 204 for IR-low and IR-high
Incidence of severe adverse events
Cumulative incidence of osteonecrosis, asparaginase associated pancreatitis and thrombosis.
Measured: From treatment day 4 until end of intervention (treatment day 169 or 204)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2019
- Study start16 Dec 2019
- Primary completion31 Jul 2023 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia, Acute LymphoblasticStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Child Cancer Foundation
- Responsible party
- Principal investigator, Renate Dagsdottir Laumann, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Thomas Leth Frandsen, Study chair, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04209244
- Sponsor's protocol ID
- H-19054660
- Status last verified
- Dec 2019
- First submitted
- 19 Dec 2019
- Last updated
- 26 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No