Nutritional Supplements and Hormonal Manipulations for Breast Cancer Prevention
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Breast Cancer |
Dietary Supplement: Lovaza Drug: Raloxifene Drug: Raloxifene 30 mg Drug: Lovaza plus Raloxifene |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Combination of Low Dose Antiestrogens With Omega-3 Fatty Acids for Prevention of Hormone-independent Breast Cancer |
- breast density [ Time Frame: baseline, q6 months for two years ] [ Designated as safety issue: No ]
- biomarkers of oxidative stress (Urinary 8-(isoprostane) F-2α and 8OHdG, Lymphocyte 8-OHdG, DNA etheno adducts) [ Time Frame: baseline, q6 months for two years ] [ Designated as safety issue: No ]
- Urinary 2-OHE1, 4-OHE1, and 16α-OHE1 [ Time Frame: baseline, q6 months for two years ] [ Designated as safety issue: No ]
- Serum level of C-reactive protein and IL-6 [ Time Frame: baseline, q6 months for two years ] [ Designated as safety issue: No ]
- Serum level of IGF-I and IGFBP-3 [ Time Frame: baseline, q6 months for two years ] [ Designated as safety issue: No ]
- lipid panel and complete blood count [ Time Frame: yearly ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 372 |
| Study Start Date: | March 2009 |
| Estimated Study Completion Date: | October 2013 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: 1
Control
|
|
|
Experimental: 2
Raloxifene 60 mg
|
Drug: Raloxifene
60 mg orally every day for two years
Other Name: Evista
|
|
Experimental: 3
Raloxifene 30 mg
|
Drug: Raloxifene 30 mg
30 mg orally daily for two years
Other Name: Evista
|
|
Experimental: 4
Lovaza 4 gm
|
Dietary Supplement: Lovaza
dietary supplement
Other Name: fish oil
|
|
Experimental: 5
Lovaza 4 gm plus Raloxifene 30 mg
|
Drug: Lovaza plus Raloxifene
Lovaza 4 gm daily plus Raloxifene 30 mg daily for two years
Other Name: fish oil, Evista
|
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.
Eligibility| Ages Eligible for Study: | 35 Years to 70 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations| United States, Pennsylvania | |
| Penn State Hershey Medical Center | |
| Hershey, Pennsylvania, United States, 17033 | |
| Principal Investigator: | Andrea Manni, MD | Penn State University |
More Information
No publications provided
| Responsible Party: | Andrea Manni, Professor and Chief Division of Endocrinology, Diabetes, and Metabolism, Milton S. Hershey Medical Center |
| ClinicalTrials.gov Identifier: | NCT00723398 History of Changes |
| Other Study ID Numbers: | 26970 |
| Study First Received: | July 24, 2008 |
| Last Updated: | January 30, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Milton S. Hershey Medical Center:
|
omega-3 fatty acids antiestrogens breast cancer prevention breast density biomarkers of mammary carcinogenesis |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Estrogen Antagonists Raloxifene |
Estrogen Receptor Modulators Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Selective Estrogen Receptor Modulators Bone Density Conservation Agents |
ClinicalTrials.gov processed this record on May 19, 2013