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Omega-3 Fatty Acids in Preventing Breast Cancer in Women at High Risk of Developing Breast Cancer

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2006 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: June 13, 2005
Last updated: September 16, 2013
Last verified: July 2006

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 Intervention
Breast Cancer
Dietary Supplement: omega-3 fatty acid

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Prevention
Official Title: A Pilot Study to Evaluate the Effects of Omega-3 Fatty Acids on Intermediate Markers of Breast Cancer

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Breast density as measured by the Madena method at 1 year

Estimated Enrollment: 80
Study Start Date: April 2005
Detailed Description:



  • 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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • At increased risk of developing breast cancer, as defined by 1 of the following criteria:

    • 5-year Gail risk ≥ 1.7%
    • Calculated 5-year Gail risk ≥ 5 times the average for age group, as defined by 1 of the following:

      • At least 0.1% (for patients age 20-29)
      • At least 1.0% (for patients age 30-39)
      • At least 1.7% (for patients age 40 and over)
    • Known BRCA1 or BRCA2 mutation carrier
    • Family history consistent with hereditary breast cancer, as defined by any of the following:

      • At least 4 relatives diagnosed with breast cancer at any age
      • At least 2 first-degree relatives diagnosed with breast cancer at age 50 or younger
      • Breast and ovarian cancer diagnosed in the same relative
      • At least 2 occurrences of breast cancer and 1 occurrence of ovarian cancer at any age in the same family
    • Atypical hyperplasia or lobular carcinoma in situ of the breast by prior biopsy
    • History of unilateral ductal carcinoma in situ of the breast
    • History of invasive stage I breast cancer in remission (completed local and systemic standard therapy)
    • History of ovarian cancer in remission for > 5 years
  • Baseline mammogram performed within the past 6 months with an interpretation of not suspicious for malignancy (BIRAD 1-3)
  • Not eligible for OR refused standard breast cancer risk reduction strategies (e.g., prophylactic oophorectomy, prophylactic mastectomy, or tamoxifen)



  • 18 and over


  • Female

Menopausal status

  • Not specified

Performance status

  • SWOG 0-1

Life expectancy

  • Not specified


  • Absolute granulocyte count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 8.0 g/dL


  • SGOT and/or SGPT ≤ 2.5 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 2.5 times ULN
  • Bilirubin ≤ 2.0 times ULN


  • Creatinine ≤ 2.0 mg/dL


  • 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


Biologic therapy

  • Not specified


  • 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


  • Not specified


  • No prior bilateral mastectomy


  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00114296

United States, California
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Cedars-Sinai Medical Center
Study Chair: Agustin Garcia, MD Cedars-Sinai Medical Center
  More Information Identifier: NCT00114296     History of Changes
Other Study ID Numbers: CDR0000430701
Study First Received: June 13, 2005
Last Updated: September 16, 2013

Keywords provided by National Cancer Institute (NCI):
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases processed this record on April 28, 2017