Nutritional Supplements and Hormonal Manipulations for Breast Cancer Prevention
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      The overall hypothesis is that the combination of a low dose of the antiestrogen Raloxifene
      with omega-3 fatty acids will exert a synergistic breast cancer chemopreventive effect due to
      the crosstalk of their downstream cellular effects leading to decreased proliferation and
      increased apoptosis of premalignant mammary cells. Based on the investigators hypothesis that
      upregulation of functional estrogen receptors in the premalignant lesions is also responsible
      for the development of hormone independent tumors, the investigators postulate that the
      combination of antiestrogens and omega-3 fatty acids will reduce the development of both
      hormone-dependent and -independent tumors. At present, there are no known interventions able
      to decrease the development of hormone-independent tumors, which are more prevalent, more
      aggressive, leading to the patient's demise. In addition, the investigators postulate that
      this approach will be safe since it will combine a lower and hence a less toxic dose of
      Raloxifene with the administration of omega-3 fatty acids which are known to have health
      benefits, i.e., reduction in cardiovascular risk, beyond their possible chemo preventive
      effect in breast cancer.
    

Detailed description: 
      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
      thromboembolic events.
    

Intervention name(s): Lovaza 4gm oral; Raloxifene 60 Mg Oral Tablet; Raloxifene 30 Mg Oral Tablet; Lovaza 4gm & Raloxifene 30mg
Intervention type(s): Dietary Supplement; Drug; Drug; Drug
Intervention description(s): Dietary supplement; Take 4 mg oral capsules daily; 60 mg orally every day for two years; 30 mg orally daily for two years; Lovaza 4gm and Raloxifene 30 Mg orally once per day for 2 years
Other intervention name(s): Omega-3 Fatty Acid Capsules; Fish Oil capsules; Triklo; Evista 60 Mg Oral Tablet; Evista 30 Mg Oral Tablet; Pitavastatin 4 gm and Evista 30 mg oral tablet
Intervention MeSH terms: Raloxifene Hydrochloride; Pitavastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: omega-3 fatty acids; antiestrogens; breast cancer prevention; breast density; biomarkers of mammary carcinogenesis