Chronic Effect of Doxorubicin and Cyclophosphamide on Neurovascular Control and Blood Pressure in Women in Adjuvant Treatment for Breast Neoplasia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Muscle sympathetic nerve activity
研究概览
简要总结
The present study aims to investigate the chronic effect of treatment with doxorubicin and cyclophosphamide on neurovascular control and blood pressure in women undergoing adjuvant treatment for breast cancer.
详细描述
The development of new drugs and different adjuvant therapeutic regimens, based on the combination of anthracycline (A) and cyclophosphamide (C), have contributed greatly to improve survival rate in breast cancer patients. Despite the clinical benefits of this therapy, AC treatment can cause cardiovascular acute and chronic changes. In a recent investigation, we observed that an acute AC chemotherapy session increases sympathetic nervous activity and blood pressure in patients with breast cancer.
The present study aims to investigate the chronic effects of AC regimen on sympathetic nervous activity, peripheral vasoconstriction, endothelial microparticles and blood pressure, in women with breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •diagnosis of stage II-III breast cancer
- •starting adjuvant chemotherapy
排除标准
- •metastatic disease,
- •hypercholesterolemia, diabetes,
- •hypertension,
- •severe lymphedema,
- •organic disorders (renal failure, heart failure and chronic liver disease),
- •obesity (BMI> 30) and,
- •who are under pharmacological treatment with statins, angiotensin-converting enzyme inhibitors, losartan potassium, beta blockers or antioxidants
研究组 & 干预措施
pre and post chemotherapy assessments
The patients will be assessed before and after chemotherapy treatment.
干预措施: Physical Characteristics (Procedure)
pre and post chemotherapy assessments
The patients will be assessed before and after chemotherapy treatment.
干预措施: Muscular Sympathetic Nervous Activity (Procedure)
pre and post chemotherapy assessments
The patients will be assessed before and after chemotherapy treatment.
干预措施: Cardiac Function (Diagnostic Test)
pre and post chemotherapy assessments
The patients will be assessed before and after chemotherapy treatment.
干预措施: Heart rate (Diagnostic Test)
pre and post chemotherapy assessments
The patients will be assessed before and after chemotherapy treatment.
干预措施: Blood pressure (Diagnostic Test)
pre and post chemotherapy assessments
The patients will be assessed before and after chemotherapy treatment.
干预措施: Blood Assessments (Diagnostic Test)
pre and post chemotherapy assessments
The patients will be assessed before and after chemotherapy treatment.
干预措施: Muscle blood flow (Diagnostic Test)
pre and post chemotherapy assessments
The patients will be assessed before and after chemotherapy treatment.
干预措施: Endothelium-dependent vascular function (Diagnostic Test)
pre and post chemotherapy assessments
The patients will be assessed before and after chemotherapy treatment.
干预措施: Vascular intima-media thickness (Diagnostic Test)
pre and post chemotherapy assessments
The patients will be assessed before and after chemotherapy treatment.
干预措施: Physical Capacity (Diagnostic Test)
pre and post chemotherapy assessments
The patients will be assessed before and after chemotherapy treatment.
干预措施: Anthracycline & Cyclophosphamide treatment scheme (Drug)
结局指标
主要结局
Muscle sympathetic nerve activity
时间窗: 15-20 days after the end of AC regimen
Change in muscular sympathetic nerve activity measured by microneurography
次要结局
- Physical capacity(15-20 days after the end of AC regimen)
- Muscle blood flow(15-20 days after the end of AC regimen)
- Blood Pressure(15-20 days after the and of AC regimen)
- Cardiac Function Impairment(15-20 days after the end of AC regimen)