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

This study is currently recruiting patients.

Sponsored by: Cedars-Sinai Medical Center
Information provided by: National Cancer Institute (NCI)

Purpose

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
 Drug: omega-3 fatty acids
 Procedure: biologically based therapies
 Procedure: cancer prevention intervention
 Procedure: chemoprevention of cancer
 Procedure: complementary and alternative therapy
 Procedure: dietary intervention
 Procedure: nutritional supplementation

MedlinePlus related topics:  Breast Cancer
Genetics Home Reference related topics:  breast cancer

Study Type: Interventional
Study Design: Prevention

Official Title: Randomized Pilot Chemoprevention Study of Omega-3 Fatty Acids in Women at High Risk of Developing Breast Cancer

Further Study Details: 

OBJECTIVES: 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.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both
Criteria

DISEASE CHARACTERISTICS:

PATIENT CHARACTERISTICS: 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

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

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00114296


California
      Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center, Los Angeles,  California,  90048,  United States; Recruiting
Agustin Garcia, MD  310-423-9364 

Study chairs or principal investigators

Agustin Garcia, MD,  Study Chair,  Cedars-Sinai Medical Center   

More Information

Clinical trial summary from the National Cancer Institute''''s PDQ® database

Study ID Numbers:  CDR0000430701; CSMC-00006359; CSMC-00000509; NCT00114296
Record last reviewed:  June 2005
Last Updated:  June 30, 2005
Record first received:  June 13, 2005
ClinicalTrials.gov Identifier:  NCT00114296
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-07-05



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