Omega-3 Fatty Acids in Preventing Breast Cancer in Women at High Risk of Developing Breast Cancer
NCT ID: NCT00114296
Last Updated: 2013-09-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
80 participants
INTERVENTIONAL
2005-04-30
Brief Summary
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PURPOSE: This randomized clinical trial is studying how well omega-3 fatty acids work in preventing breast cancer in women at high risk of developing breast cancer.
Detailed Description
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Primary
* Determine the effects of omega-3 fatty acids on mammographic breast density (MBD) in women at high risk of developing breast cancer.
Secondary
* Determine, preliminarily, the effects of this supplement on cell atypia and breast cell proliferation measured in ductal lavage specimens from these patients.
* Determine the effects of this supplement on circulating hormone and growth factor blood levels in these patients.
* Determine the effects of this supplement on the expression of estrogen-related proteins found in ductal lavage specimens from these patients.
* Determine the effects of this supplement on plasma lipid peroxidation levels in these patients.
* Correlate the modifying effect of lipid peroxidation-related genes with MBD in patients treated with this supplement.
OUTLINE: This is a randomized, pilot study. Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive oral placebo three times daily for 12 months.
* Arm II: Patients receive oral omega-3 fatty acids three times daily for 12 months.
In both arms, treatment continues in the absence of the development of ductal carcinoma in situ or invasive carcinoma of the breast or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 80 patients (40 per treatment arm) will be accrued for this study.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PREVENTION
Interventions
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omega-3 fatty acid
Eligibility Criteria
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Inclusion Criteria
Age
* 18 and over
Sex
* Female
Menopausal status
* Not specified
Performance status
* SWOG 0-1
Life expectancy
* Not specified
Hematopoietic
* Absolute granulocyte count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 8.0 g/dL
Hepatic
* SGOT and/or SGPT ≤ 2.5 times upper limit of normal (ULN)
* Alkaline phosphatase ≤ 2.5 times ULN
* Bilirubin ≤ 2.0 times ULN
Renal
* Creatinine ≤ 2.0 mg/dL
Other
* Not pregnant or nursing
* Negative pregnancy test
* No underlying medical, psychiatric, or social condition that would preclude study participation
* No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* Not specified
Endocrine therapy
* More than 6 months since prior and no concurrent hormonal therapy, including any of the following:
* Antiestrogens
* Estrogen
* Selective estrogen-receptor modulators
* Progestins
* Aromatase inhibitors
* Hormonal contraceptives
Radiotherapy
* Not specified
Surgery
* No prior bilateral mastectomy
Other
* More than 3 months since prior and no concurrent chronic (i.e., \> 3 times per week) non-steroidal anti-inflammatory drugs (e.g., aspirin, ibuprofen, or indomethacin) or cyclooxygenase-2 inhibitors
* No prior cancer treatment that would preclude study treatment
18 Years
FEMALE
No
Sponsors
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Cedars-Sinai Medical Center
OTHER
Principal Investigators
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Agustin Garcia, MD
Role: STUDY_CHAIR
Cedars-Sinai Medical Center
Locations
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Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
Los Angeles, California, United States
Countries
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Other Identifiers
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CSMC-00006359
Identifier Type: -
Identifier Source: secondary_id
CSMC-00000509
Identifier Type: -
Identifier Source: secondary_id
CDR0000430701
Identifier Type: -
Identifier Source: org_study_id