NCT05146843Unknown不适用
The Impact of Chronic Mitochondrial Antioxidant (MitoQ) Supplementation on Cardiovascular Toxicity Induced by Doxorubicin-Based Adjuvant Chemotherapy in Breast Cancer Patients: Randomized Clinical Trial
D'Or Institute for Research and Education0 个研究点目标入组 44 人开始时间: 2022年6月2日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 44
- 主要终点
- Changes of the left ventricular deformity and reduction in left ventricular ejection fraction
研究概览
简要总结
Investigate the protective effect of chronic MitoQ supplementation on cardiovascular toxicity induced by doxorubicin-based adjuvant chemotherapy in breast cancer patients.
详细描述
Test the hypothesis that chronic MitoQ supplementation in breast cancer patients treated with doxorubicin prevents:
- increased mitochondrial oxidative stress;
- the increase in cardiac markers (B-type natriuretic peptide and troponin I);
- changes in left ventricular deformity (speckle tracking, strain) and reduction in LVEF;
- endothelium-dependent dysfunction of peripheral vascular beds;
- the increase in endothelial microvesicles;
- the increase in material stiffness;
- the elevation of central blood pressure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥18 years old, diagnosed with breast cancer (ductal, lobular and mixed carcinoma), in stage 1-3, with indication for the adjuvant AC-T therapeutic scheme, doxorubicin (60 mg/m2) plus cyclophosphamide, will be considered eligible for the study (600 mg/m2) in the regimen of 1 cycle every 21 days, followed by weekly taxane for 12 cycles.
排除标准
- •Patients with metastasis, severe lymphedema, renal failure, acute myocardial infarction, heart failure, stroke and chronic liver disease.
研究组 & 干预措施
Mitoquinone
Experimental
MitoQ, 20 mg per day for three months
干预措施: Mitoquinone (Drug)
Placebo
Placebo Comparator
Placebo, 20 mg per day for three months
干预措施: Placebo (Other)
结局指标
主要结局
Changes of the left ventricular deformity and reduction in left ventricular ejection fraction
时间窗: 3 Months
Cardiac function changes (Strain and Simpson's monoplanar)
次要结局
- Systemic markers of oxidative stress(3 Months)
- Endothelium-dependent dysfunction of peripheral vascular beds(3 Months)
- Physical capacity(3 Months)
- Arterial stiffness(3 Months)
- Central blood pressure(3 Months)
研究者
Allan Robson Kluser Sales
PhD
D'Or Institute for Research and Education
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