Role of Pharmacogenetic and Psychological Factors in Methotrexate Tolerance: Studies in Children With Chronic Arthritis and Children With Leukemia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 145
- 主要终点
- Methotrexate-induced Nausea
研究概览
简要总结
Methotrexate is a cornerstone in the treatment of childhood leukemia. When given in high-dose as part of the initial phase of treatment, gastrointestinal toxicity is a known problem. However when children reach maintenance treatment with low-dose methotrexate this is not described as a significant challenge. Children with juvenile idiopathic arthritis are another patient group receiving low-dose methotrexate. Among these patients gastrointestinal intolerance is such a significant problem that treatment may be ceased. The aim of this project is to create a greater understanding of gastrointestinal intolerance associated to low-dose methotrexate treatment by investigating the differences between these two patient groups, investigating genetic and psychological factors.
详细描述
Background:
Childhood leukemia (Acute Lymphoblastic Leukemia, ALL) is the most frequent malignancy in the pediatric population (1). Survival rates have reached above 85% due to advances in chemotherapy. High-dose methotrexate (MTX) is a mainstay in the treatment of ALL (2-4). Gastrointestinal toxicity is a well known challenge associated to high-dose MTX treatment (5). However this is not described as a significant problem among these children when they reach maintenance treatment and receive low-dose MTX treatment. Children with Juvenile Idiopathic Arthritis (JIA) also receive low-dose MTX treatment. Among these patients MTX induced gastrointestinal intolerance is a significant problem. Studies have shown that more than half of the JIA patients have problems tolerating MTX because of nausea which may lead to cessation of treatment (6,7). It is largely unknown why MTX causes nausea but both pharmacogenetic and psychological factors are thought to play a role (8).
JIA is the most common chronic pediatric rheumatic disease. Without treatment the disease causes significant short- and long-term disability and quality of life impairment. Prognosis has greatly improved within recent years as a result of substantial progress in disease management and MTX is a mainstay in the treatment of JIA (9-13).
The aim of this project is to create a greater understanding of MTX induced gastrointestinal intolerance among children with leukemia and children with JIA. The project will focus on nausea and investigate the level of nausea in the two patient groups and compare if a difference does exist. The investigators will further investigate pharmacogenetic and psychological factors and their relation to the patients' level of nausea.
Pharmacogenetic background:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 9 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children diagnosed with JIA according to ILAR criteria, whom are followed at the departments of pediatrics at Aarhus University Hospital Skejby and Odense University Hospital.
- •and children diagnosed with ALL, whom are followed at the departments of pediatrics at Aarhus University Hospital Skejby, Aalborg University Hospital, Odense University Hospital and Rigshospitalet.
- •aged 9 years and above
- •currently treated with low-dose MTX for at least six weeks
排除标准
- •Children with cognitive difficulties will be excluded
- •Children without ability to speak Danish will be excluded.
结局指标
主要结局
Methotrexate-induced Nausea
时间窗: after project year 2 there will be final data analysis
"faces nausea scale" in the nausea diary
次要结局
- Methotrexate Intolerance(after project year 2 there will be final data analysis)