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Nutritional Supplements and Hormonal Manipulations for Breast Cancer Prevention

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00723398
Recruitment Status : Completed
First Posted : July 28, 2008
Last Update Posted : May 9, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Breast Cancer Dietary Supplement: Lovaza Drug: Raloxifene Drug: Raloxifene 30 mg Drug: Lovaza plus Raloxifene

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 266 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Combination of Low Dose Antiestrogens With Omega-3 Fatty Acids for Prevention of Hormone-independent Breast Cancer
Study Start Date : March 2009
Primary Completion Date : April 2015
Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. breast density [ Time Frame: baseline, q6 months for two years ]
    breast density


Secondary Outcome Measures :
  1. 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 ]
    biomarkers of oxidative stress (Urinary 8-(isoprostane) F-2α and 8OHdG, Lymphocyte 8-

  2. Urinary 2-OHE1, 4-OHE1, and 16α-OHE1 [ Time Frame: baseline, q6 months for two years ]
    Urinary 2-OHE1, 4-OHE1, and 16α-OHE1

  3. Serum level of C-reactive protein and IL-6 [ Time Frame: baseline, q6 months for two years ]
    Serum level of C-reactive protein and IL-6

  4. Serum level of IGF-I and IGFBP-3 [ Time Frame: baseline, q6 months for two years ]
    Serum level of IGF-I and IGFBP-3

  5. lipid panel and complete blood count [ Time Frame: yearly ]
    lipid panel and complete blood count


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00723398


Locations
United States, Pennsylvania
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Milton S. Hershey Medical Center
Investigators
Principal Investigator: Andrea Manni, MD Penn State University
More Information

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
First Posted: July 28, 2008    Key Record Dates
Last Update Posted: May 9, 2017
Last Verified: January 2013
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Andrea Manni, 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
Raloxifene Hydrochloride
Estrogen Receptor Modulators
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Selective Estrogen Receptor Modulators
Bone Density Conservation Agents