NCT00674011终止不适用
A Pilot Study of Hypertension in Breast Cancer Patients Receiving Bevacizumab
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- To evaluate changes in flow-mediated vasodilation (FMD) from baseline to treatment timepoints in an effort to explore the relationships between exposure to bevacizumab, eNOS activity, and vascular dysfunction.
研究概览
简要总结
This research study will look at the effect of an anti-angiogenesis medication called Bevacizumab on blood vessels. Anti-angiogenesis medicines fight cancer by cutting off a tumor's blood supply, starving the tumor of nutrients and oxygen. Previous studies have shown these types of drugs can cause hypertension. The purpose of this study is to help researchers better understand why these drugs cause hypertension. This information will assist researchers in learning how to control this side effect.
详细描述
- Participants will begin this research study within 14 days of starting Bevacizumab, either as part of standard treatment or as part of another clinical trial.
- Participants will have an ultrasound test done at baseline, and after completion of their first and second cycles of therapy.
- Vital signs and blood tests will be performed a the start of the study, and after completion of the first and second cycles of therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Histologically or cytologically confirmed breast cancer
- •Must be starting combination treatment with bevacizumab and chemotherapy. Treatment may not have already started. Patients may receive therapy either on or off of a clinical trial.
- •Any number of prior chemotherapy or biological therapy regimens is acceptable.
- •Either no history of hypertension, defined as Blood Pressure <140/90mm Hg on no antihypertensive therapy, or medically controlled pre-existing hypertension, defined as Blood Pressure < 140/90mm HG on one non-angiotensin converting enzyme inhibitor (ACE-I) or non-angiotensin receptor blocking (ARB) medication.
排除标准
- •History of uncontrolled hypertension within the previous 6 months
- •Inability to assess blood pressure or have prolonged blood pressure cuff inflation due to history of bilateral lymph node dissections, presence of an indwelling venous access device, or other condition
- •Concurrent use of a statin medication
- •Systolic blood pressure < 100mm Hg
结局指标
主要结局
To evaluate changes in flow-mediated vasodilation (FMD) from baseline to treatment timepoints in an effort to explore the relationships between exposure to bevacizumab, eNOS activity, and vascular dysfunction.
时间窗: 1 year
次要结局
- To explore whether the development of hypertension during bevacizumab therapy correlates with vascular function(1 year)
- To explore whether baseline measurements of FMD and NT are associated with the development of hypertension during bevacizumab therapy.(1 year)
研究者
Erica Mayer, MD, MPH
Principal Investigator
Dana-Farber Cancer Institute
研究点 (1)
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