Radiation Induced Atherosclerosis in Breast Cancer Patients

May 15, 2007 updated by: Hadassah Medical Organization
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

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. The contralateral artery, which received only trace of scattered radiation, can serve as the internal control. This is not the case in head and neck patients, who usually receive a high dose of radiation to both sides of the neck. The number of early breast cancer patients who received adjuvant radiation is relatively high, a factor which may help us reach the accrual goal much faster. Subsequently we are planning to proceed in a consecutive study and to try to pharmacologically interfere with progression of the AS, and perhaps even prevent it.

Intima Media Thickening US is a non-invasive US technique that is available at Hadassah University Medical Center and will be performed in this study in order to detect the degree of AS in affected and non affected arteries.

The suggested study will consist of two populations. Group 1 are women who received radiation for breast cancer in the past at various time intervals and the Group 2 are women with newly diagnosed breast cancer.

Markers and biochemistry tests that might elucidate predisposing and contributing factors for developing AS will also be done and analyzed on all patients. The latter could be a target for treatment and a surrogate to the treatment efficacy, side effects, and cancer progression (i.e. cholesterol levels, hypertension, hypothyroidism, etc.)

Study Type

Observational

Enrollment (Anticipated)

350

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jerusalem, Israel, 91120
        • Recruiting
        • Hadassah Medical Organization
        • Principal Investigator:
          • Amichay Meirovitz, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 83 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • prisoners

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Defined Population
  • Time Perspectives: Prospective

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hadassah Medical Organization

Investigators

  • Principal Investigator: Amichay Meirovitz, MD, Hadassah University Hospital, Jerusalem, Israel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Study Completion (Anticipated)

January 1, 2010

Study Registration Dates

First Submitted

October 15, 2006

First Submitted That Met QC Criteria

October 16, 2006

First Posted (Estimate)

October 17, 2006

Study Record Updates

Last Update Posted (Estimate)

May 16, 2007

Last Update Submitted That Met QC Criteria

May 15, 2007

Last Verified

December 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASBCO5- HMO-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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