Women who have a higher-than-average risk of developing breast cancer may be concerned about taking cancer prevention drugs because of some of the associated side effects. Researchers at the University of Chicago Medicine are conducting a study to find out whether flaxseed, a natural food, has the potential to be a safe and effective alternative for preventing breast cancer in women.
Participation in this trial will help researchers understand how to develop strategies for the prevention of breast cancer. Scientists do not know if this study will benefit you directly. However, flaxseed is a natural food with no known side effects.
Tremendous progress has been made in breast cancer treatments, resulting in improved outcomes. However, treatment for breast cancer is still associated with significant side effects. Fortunately, prevention of breast cancer not only reduces mortality but can reduce treatment-related complications. Still, many physicians currently recommend prevention strategies that may increase a woman's risk of certain side effects. For example, tamoxifen was originally developed to treat advanced disease but is associated with an increased risk of endometrial cancer and thrombotic events.
Many women who are at increased risk of developing breast cancer but are currently cancer-free find these side effects unacceptable and opt for screening alone. Alternative strategies are needed for chemoprevention in this high-risk population.
Flaxseed is a natural food that contains the highest source of the lignan secoisolariciresinol diglycoside (SDG) and the highest source of the ω-3 fatty acid, alpha linolenic acid (ALA). Both compounds have been shown in preliminary studies to potentially act as breast cancer prevention agents for women at high risk for developing breast cancer. In addition, flaxseed has other health benefits such as decreasing cholesterol levels, decreasing blood glucose levels in diabetics and decreasing the risk of cardiac events.
The study will last six months. Patients who agree to participate will be asked to:
- Undergo a procedure called RPFNA, which uses a fine needle to obtain breast cells. If the results of the RPFNA show that the patient is eligible for the study, she will randomly be assigned to one of two groups: Group 1 will consume 25 grams of ground flaxseed each day for six months. Group 2 will maintain a normal diet.
- Come in for assessments four times during the study: the initial visit, and at one, three and six months. Donate a small amount of blood and collect an overnight urine sample at the start of the study, and again at 1, 3 and 6 months.
- Complete a menstrual symptom diary and write down how much flaxseed is consumed.
- Undergo RPFNA again after six months to see if the flaxseed changed breast cells that affect breast cancer.
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