Status:
COMPLETED
Nutritional Supplements and Hormonal Manipulations for Breast Cancer Prevention
Lead Sponsor:
Milton S. Hershey Medical Center
Conditions:
Breast Cancer
Eligibility:
FEMALE
35-70 years
Phase:
NA
Brief 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 ...
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, postmenopausa...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
266 Patients enrolled
Trial Details
Trial ID
NCT00723398
Start Date
March 1 2009
End Date
April 1 2015
Last Update
November 1 2018
Active Locations (1)
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1
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States, 17033