Afterload Reduction Therapy for Late Anthracycline Cardiotoxicity: A Pediatric Oncology Group Cancer Control Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 61
- 主要终点
- Cardiac functional status and quality of life
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs, such as enalapril, may protect normal cells from the toxic effects of chemotherapy. It is not known whether enalapril is more effective than a placebo in treating heart damage in patients who received anthracycline chemotherapy for childhood cancer.
PURPOSE: Randomized double-blinded phase III trial to compare the effectiveness of enalapril with a placebo in treating heart damage in patients who received anthracycline chemotherapy for childhood cancer.
详细描述
OBJECTIVES: I. Determine whether enalapril treatment results in a reduction in body surface area-adjusted left ventricular mass in anthracycline-treated survivors of childhood cancer. II. Determine whether improvement in ventricular function achieved by enalapril is sustained and alters the course of late cardiotoxicity. III. Determine the impact of enalapril therapy on quality of life.
OUTLINE: This is a double blind, placebo controlled, randomized study. Patients are stratified based on the cumulative anthracycline dose, age at cancer diagnosis, and the duration of time since cessation of anthracycline therapy. Patients are administered enalapril or placebo by mouth bid. Patients undergo a series of cardiac tests after administration of drug. Follow-up occurs at 2, 6, and 12 months and every year thereafter.
PROJECTED ACCRUAL: 75 patients in each treatment arm will be accrued.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- Double
入排标准
- 年龄范围
- 8 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Stratum 1 < 350/mg/m2 anthracycline dose
< 4 years of age at diagnosis < 4 years since cessation of anthracycline treatment
干预措施: enalapril maleate (Drug)
Stratum 1 < 350/mg/m2 anthracycline dose
< 4 years of age at diagnosis < 4 years since cessation of anthracycline treatment
干预措施: quality-of-life assessment (Procedure)
Stratum 2 < 350mg/m2 anthracycline dose
< 4 years of age at diagnosis >= 4 years since cessation of anthracycline treatment
干预措施: enalapril maleate (Drug)
Stratum 2 < 350mg/m2 anthracycline dose
< 4 years of age at diagnosis >= 4 years since cessation of anthracycline treatment
干预措施: quality-of-life assessment (Procedure)
Stratum 3 < 350mg/m2 anthracycline dose
>= 4 years of age at diagnosis < 4 years since cessation of anthracycline treatment
干预措施: enalapril maleate (Drug)
Stratum 3 < 350mg/m2 anthracycline dose
>= 4 years of age at diagnosis < 4 years since cessation of anthracycline treatment
干预措施: quality-of-life assessment (Procedure)
Stratum 4 < 350mg/m2 anthracycline dose
>= 4 years of age at diagnosis >= 4 years since cessation of anthracycline treatment
干预措施: enalapril maleate (Drug)
Stratum 4 < 350mg/m2 anthracycline dose
>= 4 years of age at diagnosis >= 4 years since cessation of anthracycline treatment
干预措施: quality-of-life assessment (Procedure)
Stratum 5 >= 350mg/m2 anthracycline dose
< 4 years of age at diagnosis < 4 years since cessation of anthracycline treatment
干预措施: enalapril maleate (Drug)
Stratum 5 >= 350mg/m2 anthracycline dose
< 4 years of age at diagnosis < 4 years since cessation of anthracycline treatment
干预措施: quality-of-life assessment (Procedure)
Stratum 6 >=350mg/m2 anthracycline dose
< 4 years of age at diagnosis < 4 years since cessation of anthracycline treatment
干预措施: enalapril maleate (Drug)
Stratum 6 >=350mg/m2 anthracycline dose
< 4 years of age at diagnosis < 4 years since cessation of anthracycline treatment
干预措施: quality-of-life assessment (Procedure)
Stratum 7 >= 350mg/m2 anthracycline dose
>= 4 years of age at diagnosis < 4 years since cessation of anthracycline treatment
干预措施: enalapril maleate (Drug)
Stratum 7 >= 350mg/m2 anthracycline dose
>= 4 years of age at diagnosis < 4 years since cessation of anthracycline treatment
干预措施: quality-of-life assessment (Procedure)
Stratum 8 >= 350mg/m2 anthracycline dose
>= 4 years of age at diagnosis >= 4 years since cessation of anthracycline treatment
干预措施: enalapril maleate (Drug)
Stratum 8 >= 350mg/m2 anthracycline dose
>= 4 years of age at diagnosis >= 4 years since cessation of anthracycline treatment
干预措施: quality-of-life assessment (Procedure)
结局指标
主要结局
Cardiac functional status and quality of life
时间窗: baseline, two and five years
Cardiac functional status (depressed fractional shortening) and quality-of-life, will be assessed at baseline, two and five years into the study.
次要结局
未报告次要终点