SAlt Diet and Various Biomarkers Effects on Blood Pressure and Proteinuria During Inhibition of VEGF)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 3
- 主要终点
- Home blood pressure measurement
研究概览
简要总结
Bevacizumab is an anti-angiogenic treatment used to treat various solid cancers. Previous studies have shown that this treatment may have adverse effects like hypertension and proteinuria.
This is an exploratory study aiming to better understand the relationship between various biomarkers and blood pressure changes and proteinuria measured for 4 to 6 weeks after the first infusion of anti-VEGF therapy with bevacizumab.
详细描述
Participants will be invited to participate to this research study by their oncologist within 1 to 2 weeks before starting bevacizumab treatment, as part of standard treatment. They will finish the research at the end of the third infusion of bevacizumab.
Patients will perform a home blood pressure self-measurement over three days and will collect urine over 24 hours prior to the start of each bevacizumab infusion at cycles 1, 2 and 3. Blood pressure measurements will also be performed during each bevacizumab infusion and blood tests will be performed before each infusion to measure the following biomarkers:
- Salt consumption as estimated by 24-hour natriuresis measured before each of the first 3 infusions
- 24 hours aldosterone excretion measured before the first and third infusions
- plasma methoxylated derivatives measured before the first and third infusions
- NTproBNP measured before the first and third infusions
- 24 hours urinary free cortisol measured before the first and third infusions
- bevacizumab trough concentration measured before the first three bevacizumab infusion
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patient
- •With a solid cancer for which a treatment with bevacizumab (Avastin®) is indicated in accordance with its marketing authorization
排除标准
- •Renal cancer
- •Recent changes in antihypertensive treatment(s) in the last month, with the exception for diuretics where treatment stability of at least 3 months will be required
- •Patients who do not wish to participate to the study
结局指标
主要结局
Home blood pressure measurement
时间窗: before the initiation of bevacizumab and before each bevacizumab infusion, up to 10 weeks
Home blood pressure (systolic, diastolic) before each bevacizumab infusion, as the mean of 3 measures in the morning and 3 measures in the evening, over 3 days
次要结局
- 24-hour proteinuria(before the initiation of bevacizumab and before each bevacizumab infusion, up to 10 weeks)
- in-hospital blood pressure measurement(before the initiation of bevacizumab and before each bevacizumab infusion, up to 10 weeks)
