A Multicenter Phase II Study of Docosahexaenoic Acid (DHA) in Patients with a History of Breast Cancer, Premalignant Lesions, Benign Breast Disease.
Powel H. Brown
The goal of this clinical research study is to learn if Docosahexaenoic Acid (DHA) can help to reduce the amount of inflammation in the breasts. DHA is an omega-3 fatty acid that is normally present in the human body from the foods that you eat. Fatty fish and organ meats are the main sources of DHA, with smaller amounts coming from shellfish, eggs, and poultry. Diets rich in fish oil have been associated with a decreased risk of a number of cancers, including breast cancer. Previous studies have shown breast inflammation can increase the risk of breast cancer. The severity of breast inflammation correlates to a woman’s body mass index (a calculation based on an individual’s height and weight). Therefore, this study is being conducted only in women with a body mass index greater than or equal to 25%. We will also be studying the effect of DHA on levels of several different substances, called biomarkers, in your blood and breast tissue. These biomarkers may be used to track the amount of breast inflammation and the risk of developing breast cancer. This is a randomized study. You will be randomly assigned to get a dose of DHA or placebo. A placebo is not a drug. It looks like the study drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect. Neither you or your doctor will know whether you are getting DHA or placebo.
Treatment Location: N/A
IRB Review and Approval Date: 05/01/2013
Recruitment Status: Closed
Projected Accrual: N/A
Information and next steps
Powel H. Brown
Clinical Cancer Prevention
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