Prevention of Heart Failure Induced by Doxorubicin With Early Administration of Dexrazoxane in Patients With Breast Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Participants With 95% Reduction in Topoisomerase 2 b From Baseline
研究概览
简要总结
The purpose of this research study is to determine whether early administration of Dexrazoxane prevents Doxorubicin induced cardiotoxicity.
详细描述
This is a study on volunteers to determine effective dose of dexrazoxane in degrading Topoisomerase 2 b in human blood samples. Each participant will receive one dose of dexrazoxane. Blood samples will be collected to determine the time course and degradation of Topoisomerase 2b and Topoisomerase 2a
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 18-65,
- •Not pregnant, Not currently breast feeding
- •No current illness,
排除标准
- •Pregnancy, currently breast feeding
- •Current illness,
- •History of cardiac, or renal disease
研究组 & 干预措施
Dexrazoxane 100mg/m2
one dose of 100mg/m2 dexrazoxane
干预措施: Dexrazoxane (Drug)
Dexrazoxane 200mg/m2
one dose of 200mg/m2 dexrazoxane
干预措施: Dexrazoxane (Drug)
Dexrazoxane 300mg/m2
one dose of 300mg/m2 dexrazoxane
干预措施: Dexrazoxane (Drug)
Dexrazoxane 400mg/m2
one dose of 400mg/m2 dexrazoxane
干预措施: Dexrazoxane (Drug)
Dexrazoxane 500mg/m2
one dose of 500 mg/m2
干预措施: Dexrazoxane (Drug)
结局指标
主要结局
Participants With 95% Reduction in Topoisomerase 2 b From Baseline
时间窗: 8 hours after dexrazoxane administration
Number of participants with 95% reduction in topoisomerase 2 b from baseline is reported in the Outcome Measure Data Table
次要结局
未报告次要终点