A study regarding reducing breast density

High breast density is one of the known risk factors for breast cancer. Raloxifene (brand name Evista) is a hormonal drug that has been approved by the U.S. Food and Drug Administration (FDA) to reduce breast cancer risk in high-risk postmenopausal women, as well as to reduce bone loss. Omega-3 fatty acid is a dietary supplement that the FDA has approved to treat elevated triglyceride levels in the blood.

Studies looking at Raloxifene alone have not shown a significant change in breast density. A research team at Penn State is interested in learning whether adding an omega-3 fatty acid might have an effect on breast density.

This study is for women WITHOUT a history of breast cancer. Researchers still need many more women to participate! If you are post-menopausal, do not have a history of breast cancer, and live near or are willing to travel to Hershey, Pennsylvania, or know someone who might be interested, please read on to learn how you can take part in a breast cancer prevention study!

If this study isn’t a good fit for you, please pass it on to someone you know! Forwarding our information to friends and family is just as important as participating in a study.

What's the study about?

The purpose of this study is to find out if combining Raloxifene with a dietary supplement called omega-3 fatty acid has an effect on breast density or urine and blood chemicals associated with breast cancer development.

What's involved?

If you express interest in the Raloxifene and Omega-3 Fatty Acid Study, you need to have your next mammogram at the Breast Care Center at the Hershey Medical Center. You will be given a health-screening questionnaire so that the researchers can be sure this study is a right fit for you. After that, your mammogram will be reviewed, and if your density is read as greater than 25%, you could be eligible to participate in the study. After you sign the informed consent,you will be asked to complete a diet history and exercise questionnaire. Then, approximately eight tablespoons of blood will be collected and you will be asked to collect your first morning urine for three consecutive days. Finally, you will be randomly assigned (like the flip of a coin) to either a group taking no treatment or to one of four other groups which include Raloxifene at 60 mg or 30 mg, or just omega-3 fatty acid or a combination of the lower dose of Raloxifene and omega-3 fatty acid. Over the course of the study, you will meet with the research team every six months for two years.

The researchers will discuss all study procedures, any possible risk factors, and answer all questions you may have.

Approximately 372 women will be enrolled in this study.

Who is conducting the study?

Andrea Manni, MD, at Penn State Milton S. Hershey Medical Center in Hershey, PA

Where?

Penn State Milton S. Hershey Medical Center in Hershey, PA

Who can participate?

You can join the Raloxifene and Omega-3 Fatty Acid Study if you match ALL of these MAIN categories:

• You are post-menopausal (at least 12 months without a menstrual cycle)
• You have never had breast cancer
• You have NOT been on hormone replacement therapy during the past 6 months
• You have NOT taken Raloxifene during the past 6 months
• You are a non-smoker (never smoked or smoke free for more than 5 years)
• You are woman between the ages of 35 and 75
• You live near or are willing to travel to the Penn State Milton S. Hershey Medical Center in Hershey, PA

For more information or to sign up, just follow the link!

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