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Combination of Low Dose Antiestrogens With Omega-3 Fatty Acids for Prevention of Hormone-independent Breast Cancer


N/A
35 Years
70 Years
Open (Enrolling)
Female
Breast Cancer

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Trial Information

Combination of Low Dose Antiestrogens With Omega-3 Fatty Acids for Prevention of Hormone-independent 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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

breast density

Outcome Time Frame:

baseline, q6 months for two years

Safety Issue:

No

Principal Investigator

Andrea Manni, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Penn State University

Authority:

United States: Institutional Review Board

Study ID:

26970

NCT ID:

NCT00723398

Start Date:

March 2009

Completion Date:

October 2013

Related Keywords:

  • Breast Cancer
  • omega-3 fatty acids
  • antiestrogens
  • breast cancer prevention
  • breast density
  • biomarkers of mammary carcinogenesis
  • Breast Neoplasms

Name

Location
Penn State Hershey Medical Center Hershey, Pennsylvania  17033