- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00723398
Nutritional Supplements and Hormonal Manipulations for Breast Cancer Prevention
Combination of Low Dose Antiestrogens With Omega-3 Fatty Acids for Prevention of Hormone-independent Breast Cancer
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Hershey, Pennsylvania, United States, 17033
- Penn State Hershey Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Group 1: Control
Control, no intervention
|
|
Experimental: Group 2: Raloxifene 60 Mg Oral Tablet
Raloxifene 60 mg Orally Daily
|
60 mg orally every day for two years
Other Names:
|
Experimental: Group 3: Raloxifene 30 Mg Oral Tablet
Raloxifene 30 mg Orally Daily
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30 mg orally daily for two years
Other Names:
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Experimental: Group 4: Lovaza 4 gm oral
Lovaza 4 gm/day Orally with Meals
|
Dietary supplement; Take 4 mg oral capsules daily
Other Names:
|
Experimental: Group 5: Lovaza 4gm & Raloxifene 30mg
Lovaza 4 gm/day oral capsule with meals plus Raloxifene 30 mg oral tablet daily
|
Lovaza 4gm and Raloxifene 30 Mg orally once per day for 2 years
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Absolute Breast Density
Time Frame: 2 years
|
Change of absolute breast density as indicated by mammography from baseline to Year +1 and completion of study (Year +2).
No other mammograms will be obtained or used for the purpose of this study.
Absolute breast density volume is based on breast thickness and the x-ray attenuation at each pixel of the image.
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Biomarkers for Oxidative Stress:Urinary 8-(Isoprostane) F-2α
Time Frame: 1 year
|
Changes in biomarkers for oxidative stress.
Specific time points for evaluation are baseline and Year +1 (only).
Urinary 8-(isoprostane) F-2α as measured through urine analysis.
|
1 year
|
Changes in Biomarkers for Oxidative Stress: Urinary 8-hydroxy-deoxyguansine
Time Frame: 1 year
|
Changes in biomarkers for oxidative stress.
Specific time points for evaluation are baseline and Year +1 (only).
Urinary 8-hydroxy-deoxyguansine as measured through urinary analysis.
|
1 year
|
Changes in Biomarkers for Estrogen Metabolism: 2-hydroxy Estrone (Urinary 2-OHE1) and 16-α-hydroxy Estrone (16α-OHE1)
Time Frame: 1 year
|
Changes in biomarkers for estrogen metabolism: 2-hydroxy estrone (Urinary 2-OHE1) and 16-α-hydroxy estrone (16α-OHE1) as measured by urinary analysis.
Specific time points for evaluation are baseline and Year +1 (only).
|
1 year
|
Changes in Serum Biomarkers for Inflammation From Levels of High Sensitivity C-reactive Protein (hsCRP) and Interleukin 6 (IL-6)
Time Frame: 1 Year
|
Changes in serum biomarkers for inflammation including highly sensitive C-reactive protein and IL-6 obtained through a blood draw.
Specific time points for evaluation are baseline and Year +1 (only).
|
1 Year
|
Changes in Insulin-like Growth Factor-1 (IGF-1) and Insulin-like Growth Factor-1 Binding Protein-3 (IGFBP-3)
Time Frame: 1 year
|
Changes in insulin-like growth factor-1 (IGF-1) and insulin-like growth factor-1 binding protein-3 (IGFBP-3) obtained through blood sample.
Specific time points for evaluation are baseline and Year +1 (only).
|
1 year
|
Changes in Serum Lipid Levels
Time Frame: 2 years
|
Changes in serum lipid levels as measured through total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, and triglycerides.
Specific time points for evaluation are baseline, Year +1, and Year 2.
|
2 years
|
Changes in Complete Blood Count: Red Blood Cells
Time Frame: 2 years
|
Changes in complete blood count levels as measured through red blood cells (RBC).
Specific time points for evaluation are baseline, Year +1, and Year 2.
|
2 years
|
Changes in Complete Blood Count: Hemoglobin
Time Frame: 2 years
|
Changes in complete blood count levels as measured through hemoglobin.
Specific time points for evaluation are baseline, Year +1, and Year 2.
|
2 years
|
Changes in Complete Blood Count: Hematocrit
Time Frame: 2 years
|
Changes in complete blood count levels as measured through hematocrit percentage.
Specific time points for evaluation are baseline, Year +1, and Year 2.
|
2 years
|
Changes in Complete Blood Count: White Blood Cells and Platelets
Time Frame: 2 years
|
Changes in complete blood count levels as measured through white blood cells (WBC) and platelets.
Specific time points for evaluation are baseline, Year +1, and Year 2.
|
2 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Andrea Manni, MD, Penn State University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Hormone Antagonists
- Bone Density Conservation Agents
- Estrogen Antagonists
- Selective Estrogen Receptor Modulators
- Estrogen Receptor Modulators
- Raloxifene Hydrochloride
- Pitavastatin
Other Study ID Numbers
- 26970
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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