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临床试验/NCT00388713
NCT00388713Unknown不适用

Radiation Induced Atherosclerosis in Breast Cancer Patients

Hadassah Medical Organization1 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2006年10月最近更新:
适应症

试验速览

阶段
不适用
入组人数
350
试验地点
1

研究概览

简要总结

Radiation induced accelerated atherosclerosis is a well known entity that occurs in different regions, according to the therapy delivered.It is usually begins to be clinically evident several years after the radiation incident, as there is sufficient functional reserve to these vessels.Our proposal is aimed to better characterize this side effect. For that purpose, we have chosen to study women who received radiation to the breast, in which part of the carotid in the irradiated side was in the high energy radiation field. We will use Intima Media Thickening ultrasound to study the pattern of atherosclerosis plaque formation in radiated carotid arteries as compared to non-irradiated carotid arteries in women who are receiving radiation therapy for breast cancer.

详细描述

Radiation induced atherosclerosis in Breast Cancer patients

Radiation induced accelerated atherosclerosis is a well known entity that occurs in different regions, according to the therapy delivered. This process takes a couple of years to develop. Therefore, the most affected populations are the long term survivors of potentially curative cancers such as Hodgkins lymphoma 1, 2, head and neck cancers 3-6, pelvic cancers (both prostate cancer and cervical cancer) 7, and breast cancer8-14. The mechanism of damage is thought to be direct endothelial damage, which is most significant about 6 months post XRT, followed by inflammation, cholesterol plaque formation and intimal thickening. This cascade, as well as the pathological findings, are similar to what is seen in natively occurring AS. However, in the post XRT setup, it is not limited to one part of the artery and usually encompasses the entire circumference of the radiated segment15-17.

The accelerated atherosclerosis resulting from radiation usually begins to be clinically evident several years after the radiation incident, as there is sufficient functional reserve to these vessels. However, changes can be seen much sooner, and some studies have shown significant changes as soon as one year after the initial insult 2, 18.

Literature reports suggest as high as 77.5% of symptomatic carotid stenosis (on risky regions of common carotid and internal carotid arteries) as compared to 21.6% on the matched control group (consisting of newly diagnosed patients with similar risk factors)18. A retrospective review from Philadelphia on 413 treated patients found RR for stroke of 2, as compared with the general population (matched for risk factors) from the Stockholm database5. Data from the Netherlands suggested risk for stroke as high as 5 times as compared to the matched group without cancer. The analysis was done on patients who received the treatment before 60 yo (the comparison was not made to the general population as these patient are usually smokers and drinkers and are usually at a higher risk to begin with, however XRT increases this already high risk by 5).

A new emerging technique of Carotid Intima-Media Thickening (IMT) has demonstrated the impact of radiation (2.2 Vs 0.7mm in controls)6.

研究设计

研究类型
Observational
观察模型
Defined Population
时间视角
Prospective

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • women 18-85 Y.O.
  • received or about to receive unilateral breast and supraclavicular radiation therapy
  • No evidence of disease

排除标准

  • prisoners

研究者

申办方类型
Other

研究点 (1)

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