Nutritional Supplements and Hormonal Manipulations for Breast Cancer Prevention
Completed · Not applicable
Conditions studied: Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT00723398
- Run by
- Milton S. Hershey Medical Center
- People needed
- 266
- Starts
- 2009-03-01
- Expected to finish
- 2015-04-01
- Last updated by the study team
- 2018-11-01
Who can join
Age: 35 and older, up to 70. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Penn State Hershey Medical Center — Hershey, Pennsylvania, United States
Full record on ClinicalTrials.gov
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