Effect of Fish Oil Versus Placebo on Hyperlipidemia and Toxicities in Children and Young Adults With Acute Lymphoblastic Leukemia - A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 5
- 主要终点
- Hyperlipidemia
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Patients diagnosed with ALL, stratified to high risk (HR) after induction treatment or stem cell transplantation in the ALLTogether protocol
结局指标
主要结局
Hyperlipidemia
时间窗: 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.
次要结局
- Compliance(From treatment day 4 until end of intervention (treatment day 169 or 204))
- 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.)
- 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)
- Incidence of severe adverse events(From treatment day 4 until end of intervention (treatment day 169 or 204))
研究者
Renate Dagsdottir Laumann
Principal Investigator
Rigshospitalet, Denmark