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
Primary Objectives: 1. To determine whether treatment with docosahexaenoic acid (DHA) for 12(+2 weeks) weeks at 1000mg twice daily as compared to placebo reduces normal breast tissue levels of TNF-a in overweight and obese patients with a history of stage I-III invasive breast cancer, or ductal carcinoma in situ (DCIS), Paget's disease, lobular carcinoma in situ (LCIS), or proliferative benign breast disease. Secondary Objectives: 1. To investigate the effect of DHA at 1000mg twice daily on tissue biomarkers We will determine the change from the baseline in: COX-2/IL-1beta/aromatase measured by quantitative real-time PCR. Crown-like Structures of the breast (CLS-B) measured by immunohistochemical techniques for CD68. Total number of CLS-B/slide will be recorded. CLS-B index determined as follows: [(number of slides with evidence of at least one CLS-B) / (total number of slides examined)]. CLS-B/cm2 defined as the number of CLS-B/cm2 Gene expression by RNA-seq 2. Evaluate age as a predictor of CLS-B and inflammatory biomarkers (TNF-a/COX-2/IL-1beta at baseline and over the time of treatment. 3. Evaluate RBC fatty acid level as a surrogate of compliance.
IRB Review and Approval Date: 05/01/2013
Recruitment Status: Closed
Projected Accrual: N/A
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Powel H. Brown
Clinical Cancer Prevention
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