Combination of Low Dose Antiestrogens With Omega-3 Fatty Acids for Prevention of Hormone-independent Breast Cancer
The main objectives of this study are to determine the individual and combined effects of
Raloxifene and omega-3 fatty acids on surrogate markers of breast cancer development in
healthy, postmenopausal women. The primary endpoint will be mammographic density for which
the study has been powered. Breast density is a major risk factor for breast cancer and
hence it is chosen to evaluate the potential chemopreventive efficacy of our interventions.
Secondary endpoints would include markers of oxidative stress, parameters of estrogen
metabolism, markers of inflammation, and markers of IGF-I signaling, all of which have been
shown in the literature to have an influence on mammary carcinogenesis.
Study Population: Healthy, postmenopausal women between the ages of 35-70 years,
undergoing yearly mammograms as part of routine screening practice.
Method of Identification of Subjects/Samples/Medical Records: Women reporting for yearly
mammograms will be considered for this protocol. They will be given first a screening
questionnaire to rule out any co-existing medical condition that would predispose them to
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
baseline, q6 months for two years
Andrea Manni, MD
Penn State University
United States: Institutional Review Board
|Penn State Hershey Medical Center||Hershey, Pennsylvania 17033|