NCT00114296Unknown不适用
A Pilot Study to Evaluate the Effects of Omega-3 Fatty Acids on Intermediate Markers of Breast Cancer
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Breast density as measured by the Madena method at 1 year
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Prevention
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •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)
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Menopausal status
- •Not specified
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •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
- •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
- •Selective estrogen-receptor modulators
- •Progestins
- •Aromatase inhibitors
- •Hormonal contraceptives
- 另有 5 项未显示
排除标准
- 未提供
结局指标
主要结局
Breast density as measured by the Madena method at 1 year
次要结局
未报告次要终点
研究者
研究点 (1)
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