Hepatoprotective Measures for Children and Adolescents With Acute Lymphoblastic Leukemia During Induction Chemotherapy
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Implementation a program of hepatic support
研究概览
简要总结
This current study will implement a proposed whole program of monitoring and prevention acute hepatic injury during the time of induction chemotherapy in children and adolescent with ALL.
详细描述
Children and adolescent with acute lymphoblastic leukemia (ALL) can exhibit a wide spectrum of hepatotoxicity ranging from asymptomatic to clinically significant during induction chemotherapy. Unmonitored hepatic status can lead to a hepatic toxicity that might result in unwarranted interruption of the aimed delivery of dose dense chemotherapy to induce remission and consequent treatment.
To evaluate the effect of chemotherapy in children and adolescent with ALL during induction phase, through recording liver function tests before, during and after induction chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children and adolescents aged from 2 to 18 years newly diagnosed with acute lymphoblastic leukemia during induction phase of chemotherapy treated at Ain Shams
排除标准
- •Known chronic liver disease.
研究组 & 干预措施
Retrospective historical control
Retrospective historical control (Arm 1): Children and adolescent with ALL received Total XV induction chemotherapy from 1st June 2018 till 30th April 2023
Interventional arm (Arm 2):Children and adolescent with ALL receiving Total XV induction chemotherap
Implementation of hepatic supportive program
- Dietary modification: Patients will follow Mediterranean Diet (MD), this diet is characterized by a high intake of vegetables, fruit, whole cereals, legumes, nuts, and fish and a low intake of red meat and homemade desserts. The main added fat was extra virgin olive oil, with 35-40% kcal from fat (<10% from saturated fat), 40-44% kcal from carbohydrate, and 20% kcal from protein
- Evaluation of the risk of malnutrition in hospitalized children with cancer through SCAN score which is simple, quick and valid tool. A score of 0 - 1indicates a low risk of malnutrition. A score of 2 indicates a moderate risk of malnutrition. A score of 3 - 5 indicates a high risk of malnutrition.
- Supplementation of omega 3 fatty acids ( dose based on weight: <40 kg-450 mg/day, 40-60 kg-900 mg/day, >60 kg-1300 mg/day)
干预措施: Dietary modification (Dietary Supplement)
Interventional arm (Arm 2):Children and adolescent with ALL receiving Total XV induction chemotherap
Implementation of hepatic supportive program
- Dietary modification: Patients will follow Mediterranean Diet (MD), this diet is characterized by a high intake of vegetables, fruit, whole cereals, legumes, nuts, and fish and a low intake of red meat and homemade desserts. The main added fat was extra virgin olive oil, with 35-40% kcal from fat (<10% from saturated fat), 40-44% kcal from carbohydrate, and 20% kcal from protein
- Evaluation of the risk of malnutrition in hospitalized children with cancer through SCAN score which is simple, quick and valid tool. A score of 0 - 1indicates a low risk of malnutrition. A score of 2 indicates a moderate risk of malnutrition. A score of 3 - 5 indicates a high risk of malnutrition.
- Supplementation of omega 3 fatty acids ( dose based on weight: <40 kg-450 mg/day, 40-60 kg-900 mg/day, >60 kg-1300 mg/day)
干预措施: Supplementation of omega 3 fatty acids (Dietary Supplement)
结局指标
主要结局
Implementation a program of hepatic support
时间窗: Almost 1 year
To implement a hepatoprotection interventional program to children and adolescent with ALL during Total XV induction c
次要结局
未报告次要终点