Nutritional Supplements and Hormonal Manipulations for Breast Cancer Prevention
| Status: | Completed |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 35 - 70 |
| Updated: | 11/3/2018 |
| Start Date: | March 2009 |
| End Date: | April 2015 |
Combination of Low Dose Antiestrogens With Omega-3 Fatty Acids for Prevention of Hormone-independent Breast Cancer
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.
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.
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.
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.
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.
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