Effect of Fish Oil Versus Placebo on Hyperlipidemia and Toxicities in Children and Young Adults With Acute Lymphoblastic Leukemia - A Randomized Controlled Trial

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 45
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Denmark
Aalborg University Hospital
NOT_YET_RECRUITING
Aalborg
Aarhus University Hospital
NOT_YET_RECRUITING
Aarhus
Rigshospitalet
RECRUITING
Copenhagen
Odense University Hospital
NOT_YET_RECRUITING
Odense
Contact Information
Primary
Renate Dagsdottir Laumann, MSc
renate.dagsdottir.laumann@regionh.dk
+4560163957
Time Frame
Start Date: 2019-12-16
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 100
Treatments
Experimental: Fish oil
Eskimo-3 Pure Fish Oil, 10 ml per day (2.6 g EPA+DHA)
Placebo_comparator: Placebo
Rapeseed Oil, 10 ml per day
Sponsors
Leads: Rigshospitalet, Denmark
Collaborators: Danish Child Cancer Foundation

This content was sourced from clinicaltrials.gov