Omega-3 Fatty Acids in Preventing Breast Cancer in Women at High Risk of Developing Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00114296|
Recruitment Status : Unknown
Verified July 2006 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : June 14, 2005
Last Update Posted : September 17, 2013
RATIONALE: Chemoprevention is the use of certain drugs or supplements to keep cancer from forming, growing, or coming back. The use of omega-3 fatty acids may prevent breast cancer.
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Dietary Supplement: omega-3 fatty acid||Not Applicable|
- Determine the effects of omega-3 fatty acids on mammographic breast density (MBD) in women at high risk of developing breast cancer.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Official Title:||A Pilot Study to Evaluate the Effects of Omega-3 Fatty Acids on Intermediate Markers of Breast Cancer|
|Study Start Date :||April 2005|
- Breast density as measured by the Madena method at 1 year
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): NCT00114296
|United States, California|
|Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center|
|Los Angeles, California, United States, 90048|
|Study Chair:||Agustin Garcia, MD||Cedars-Sinai Medical Center|