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

NCT04209244 | Recruiting

• 1 other identifier: H-19054660
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 4

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.

Conditions

Leukemia, Acute Lymphoblastic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Lipid metabolism

  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

  From treatment day 4 until end of intervention (treatment day 169 or 204)

• Bone density

  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

  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

  At treatment day 4, 81 and 169 for VLR and at treatment day 4, 102 and 204 for IR-low and IR-high

Other Outcomes (2)

• Milder side effects

  At end of intervention (day 169 or 204)

• Dietary intake

  At treatment day 4, 81 and 169 for VLR and at treatment day 4, 102 and 204 for IR-low and IR-high

Study Arms (2)

Fish oil

EXPERIMENTAL

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

Dietary Supplement: Eskimo-3 Pure Fish Oil

Placebo

PLACEBO COMPARATOR

Rapeseed Oil, 10 ml per day

Dietary Supplement: Rapeseed Oil

Interventions

Eskimo-3 Pure Fish Oil DIETARY_SUPPLEMENT

Dosage: 10 ml/day (2.6 g EPA+DHA)

Also known as: Fish Oil

Fish oil

Rapeseed Oil DIETARY_SUPPLEMENT

Dosage: 10 ml/day (0 g EPA+DHA)

Also known as: Placebo

Placebo

Eligibility Criteria

• Age: 1 Year - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Patients diagnosed with ALL, stratified to high risk (HR) after induction treatment or stem cell transplantation in the ALLTogether protocol

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Danish Child Cancer Foundation: collaborator

Study Sites (4)

Aalborg University Hospital

Aalborg, Denmark

NOT YET RECRUITING

Aarhus University Hospital

Aarhus, Denmark

NOT YET RECRUITING

Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

Odense University Hospital

Odense, Denmark

NOT YET RECRUITING

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Fish Oils; Rapeseed Oil

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Oils; Lipids; Plant Oils; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Thomas Leth Frandsen

  Rigshospitalet, Denmark

  STUDY CHAIR

Central Study Contacts

Renate Dagsdottir Laumann, MSc

CONTACT

+4560163957; renate.dagsdottir.laumann@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 19, 2019
• First Posted: December 24, 2019
• Study Start: December 16, 2019
• Primary Completion: July 31, 2023
• Study Completion (Estimated): December 31, 2029
• Last Updated: December 26, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (4)