The Multi-centers Trial for Patients With Non-Hodgkin's Lymphoma to Assess the Protective Effect of Valsartan on Chronic Cardiotoxicity Induced by CHOP
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Cardiac Event after 3rd and 6th course of CHOP(-R)
研究概览
简要总结
The purpose of this study is to assess the protective effect of Valsartan on chronic cardiotoxicity induced by CHOP.
详细描述
Doxorubicin has been one of the most important key drugs in treatment for malignancies. However, its use is limited by dose-dependent cumulative cardiotoxicity. This multi-centers trial was designed to investigate the preventive effect of Valsartan, the angiotensin II type 1 receptor blocker (ARB) on chronic cardiotoxicity due to doxorubicin based chemotherapy. Patients with untreated non-Hodgkin's lymphoma who are scheduled to receive at least 6 courses of the standard CHOP (-R) will be randomized by the minimization methods to the treatment group with Valsartan (80mg once daily by oral during entire 6 courses of CHOP) or control group. Cardiac function will be evaluated in detail before and after 3 and 6 courses of CHOP (-R).
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
- None
入排标准
- 年龄范围
- 15 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of non-Hodgkin's lymphoma (NHL)
- •Untreated lymphoma
- •Performance status from 0 to 1,
- •Total serum bilirubin < 2.0 mg/dl
- •Serum creatinine level < 2.0 mg/dl
- •Ejection fraction of the left ventricle >50 %
- •Systolic blood pressure at rest being 90 mmHg or more
排除标准
- •Severe complication including chronic or acute heart failure, angina, old myocardial infarction, liver cirrhosis, and interstitial pneumonia
- •Pregnancy, nursing mothers or women of child-bearing potential
- •Hypertension under medication
- •Diabetes mellitus under medication
- •Hyperthyroidism, nephrotic syndrome, Cushing's syndrome
- •Atrial arrythmias
- •Severe psychopathy
- •Cerebrovascular accidents within the past 3 months
- •Positive serum HBs antigen or HCV antibody
- •A history of renal failure
- •A contraindication to A-II antagonists or noncompliance
- •Treatment with any of the following drugs within the past 3 months : A-II antagonists, ACE inhibitors, vitamin E, probucol, calcium antagonists, beta-blockers, and steroid pulse therapy.
研究组 & 干预措施
ARB administration
80mg/day from the day of the start of 1st CHOP until the completion of all the evaluations
干预措施: Valsartan (Drug)
结局指标
主要结局
Cardiac Event after 3rd and 6th course of CHOP(-R)
时间窗: Basically 14-21 (at a maximum 28) days after the start of 3rd and 6th course of CHOP(-R).
次要结局
- Changes of ECG, UCG and serum markers after 3 and 6 courses of CHOP (-R)(14-21 (at a maximum 28) days after the start of 3rd and 6th course of CHOP(-R).)