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Sponsored by: |
Penn State University |
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Information provided by: | Penn State University |
ClinicalTrials.gov Identifier: | NCT00723398 |
The investigators 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.
Condition | Intervention |
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Breast Cancer |
Dietary Supplement: Lovaza Drug: Raloxifene Drug: Raloxifene 30 mg Drug: Lovaza plus Raloxifene |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Combination of Low Dose Antiestrogens With Omega-3 Fatty Acids for Prevention of Hormone-Independent Breast Cancer |
Estimated Enrollment: | 372 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | October 2012 |
Estimated Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: No Intervention
Control
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2: Experimental
Raloxifene 60 mg
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Drug: Raloxifene
60 mg orally every day for two years
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3: Experimental
Raloxifene 30 mg
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Drug: Raloxifene 30 mg
30 mg orally daily for two years
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4: Experimental
Lovaza 4 gm
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Dietary Supplement: Lovaza
dietary supplement
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5: Experimental
Lovaza 4 gm plus Raloxifene 30 mg
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Drug: Lovaza plus Raloxifene
Lovaza 4 gm daily plus Raloxifene 30 mg daily for two years
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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.
Ages Eligible for Study: | 35 Years to 70 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Andrea Manni, M.D. | 717-531-8395 | amanni@hmc.psu.edu |
United States, Pennsylvania | |
Penn State Hershey Medical Center | |
Hershey, Pennsylvania, United States, 17033 |
Principal Investigator: | Andrea Manni, MD | Penn State University |
Responsible Party: | Penn State College of Medicine ( Andrea Manni, M.D., Professor of Medicine ) |
Study ID Numbers: | 26970 |
Study First Received: | July 24, 2008 |
Last Updated: | July 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00723398 History of Changes |
Health Authority: | United States: Institutional Review Board |
omega-3 fatty acids antiestrogens breast cancer prevention breast density biomarkers of mammary carcinogenesis |
Estrogen Receptor Modulators Estrogens Estrogen Antagonists Raloxifene Skin Diseases Hormone Antagonists |
Hormones, Hormone Substitutes, and Hormone Antagonists Breast Neoplasms Bone Density Conservation Agents Selective Estrogen Receptor Modulators Hormones Breast Diseases |
Estrogen Antagonists Skin Diseases Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Breast Neoplasms Bone Density Conservation Agents |
Selective Estrogen Receptor Modulators Pharmacologic Actions Estrogen Receptor Modulators Neoplasms Raloxifene Neoplasms by Site Breast Diseases |