Nutritional Supplements and Hormonal Manipulations for Breast Cancer Prevention
Information source: Penn State University
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Breast Cancer
Intervention: Lovaza (Dietary Supplement); Raloxifene (Drug); Raloxifene 30 mg (Drug); Lovaza plus Raloxifene (Drug)
Phase: N/A
Status: Not yet recruiting
Sponsored by: Penn State University Official(s) and/or principal investigator(s):
Andrea Manni, MD, Principal Investigator, Affiliation: Penn State University
Overall contact:
Andrea Manni, M.D., Phone: 717-531-8395, Email: amanni@hmc.psu.edu
Summary
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.
Clinical Details
Official title: Combination of Low Dose Antiestrogens With Omega-3 Fatty Acids for Prevention of Hormone-Independent Breast Cancer
Study design: Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Primary outcome: breast density
Secondary outcome: biomarkers of oxidative stress (Urinary 8-(isoprostane) F-2α and 8OHdG, Lymphocyte 8-OHdG, DNA etheno adducts)Urinary 2-OHE1, 4-OHE1, and 16α-OHE1 Serum level of C-reactive protein and IL-6 Serum level of IGF-I and IGFBP-3 lipid panel and complete blood count
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
Minimum age: 35 Years.
Maximum age: 70 Years.
Gender(s): Female.
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.
Locations and Contacts
Andrea Manni, M.D., Phone: 717-531-8395, Email: amanni@hmc.psu.edu
Penn State Hershey Medical Center, Hershey, Pennsylvania 17033, United States
Additional Information
Starting date: September 2008
Ending date: October 2012
Last updated: July 24, 2008
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