Nutritional Supplements and Hormonal Manipulations for Breast Cancer Prevention

• Status: Completed
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Milton S. Hershey Medical Center
• Treatments: Estrogen Receptor Modulators; Pitavastatin; Raloxifene Hydrochloride

Criteria

Inclusion Criteria:

• Postmenopausal status defined as history of at least 12 months without spontaneous menstrual bleeding or a documented hysterectomy and bilateral salpingo oophorectomy

• Breast density greater than 25%

• No hormone replacement therapy for at least six months prior to entry into this study

• Non-smokers.

Exclusion Criteria:

• History of stroke, pulmonary embolism or deep vein thrombosis

• History of atherosclerotic heart disease

• Presence of any known hypercoagulable state either congenital (e.g., protein S deficiency) or acquired (e.g., corticosteroid treatment)

• Diabetes mellitus

• Uncontrolled hypertension (BP ≥140/90)

• Presence of a psychiatric condition that would interfere with adherence to the protocol.