A Randomized, Placebo-Controlled Phase II Clinical Trial of Omega-3 PUFA Dietary Supplementation in Patients With Stage I-III Breast Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- PUFA Levels in Normal and Metastatic Breast Tissue
研究概览
简要总结
This phase II clinical trial studies how well omega-3 fatty acid works in treating patients with stage I-III breast cancer. Studying samples of tissue and blood in the laboratory from breast cancer patients receiving omega-3 fatty acid may help doctors learn more about the effects of omega-3 fatty acid on tumor cells.
详细描述
PRIMARY OBJECTIVES:
I. To determine if omega-3 dietary supplementation (omega-3 fatty acid) results in higher polyunsaturated fatty acids (PUFA) levels in surgical specimens of normal and malignant breast tissue in women who took omega 3 tablets in comparison to those who took placebo.
II. To determine if omega-3 dietary supplementation results in higher PUFA levels in plasma and red blood cells in women who took omega 3 tablets in comparison to those who took placebo.
III. To determine if omega-3 dietary supplementation affects the metabolites of omega-3 and omega-6 PUFA in surgical specimens of malignant and normal breast tissue in comparison to controls.
IV. To determine if women who take omega-3 dietary supplementation have less proliferation and greater apoptosis in malignant breast tissue in comparison to women who take placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed stage I to III breast cancer and carcinoma in situ (including lobular carcinoma in situ [LCIS] and ductal carcinoma in situ [DCIS])
- •Breast surgery (lumpectomy or mastectomy) is planned for at least 7 days from the day of enrollment
- •Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved written informed consent document
- •Tumor measures at least 1 centimeter on imaging or physical exam
排除标准
- •Any patient with surgery scheduled < 7days after biopsy
- •Patients who are unable to refrain from the use of any NSAID or full-dose acetylsalicylic acid (ASA)-containing NSAID while taking study drug
- •Patients who will receive neoadjuvant chemotherapy are not eligible
- •Patients who are currently taking omega-3 fatty acids, as they are unable to be randomized to placebo
- •Patients who have previously taken omega-3 fatty acid within 1 month prior to study enrollment
- •Patients with an allergy or known hypersensitivity to fish
研究组 & 干预措施
Arm I (omega-3 fatty acid)
Patients receive omega-3 fatty acid PO daily for 7-14 days.
干预措施: omega-3 fatty acid (Drug)
Arm I (omega-3 fatty acid)
Patients receive omega-3 fatty acid PO daily for 7-14 days.
干预措施: laboratory biomarker analysis (Other)
Arm II (placebo)
Patients receive placebo PO daily for 7-14 days.
干预措施: placebo (Other)
Arm II (placebo)
Patients receive placebo PO daily for 7-14 days.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
PUFA Levels in Normal and Metastatic Breast Tissue
时间窗: At time of surgery
Analysis of variance (ANOVA) will be used to assess the effect of omega-3 dietary supplementation on PUFA levels separately in normal and malignant breast tissue. Analysis of covariance (ANCOVA) will be used to assess the omega-3 effect in plasma and red blood cells (RBC), where the baseline levels of the PUFAs will be included as covariates. PUFA Levels analyzed were 18:2 n-6, 18:3 n-3, 20:2 n-6, 20:4 n-6, 20:3 n-3, 20:5 n-3, 22:6 n-3
PUFA Levels in Plasma Pre and Post Surgery
时间窗: Pre and post surgery
Analysis of variance (ANOVA) will be used to assess the effect of omega-3 dietary supplementation on PUFA levels separately in normal and malignant breast tissue. Analysis of covariance (ANCOVA) will be used to assess the omega-3 effect in plasma and red blood cells (RBC), where the baseline levels of the PUFAs will be included as covariates. PUFA Levels analyzed were 18:2 n-6, 18:3 n-3, 20:2 n-6, 20:4 n-6, 20:3 n-3, 20:5 n-3, 22:6 n-3
PUFA Levels in Red Blood Cells Pre and Post Surgery
时间窗: Pre and post surgery
Analysis of variance (ANOVA) will be used to assess the effect of omega-3 dietary supplementation on PUFA levels separately in normal and malignant breast tissue. Analysis of covariance (ANCOVA) will be used to assess the omega-3 effect in plasma and red blood cells (RBC), where the baseline levels of the PUFAs will be included as covariates. PUFA Levels analyzed were 18:2 n-6, 18:3 n-3, 20:2 n-6, 20:4 n-6, 20:3 n-3, 20:5 n-3, 22:6 n-3
次要结局
- Metabolites of Omega-3 and Omega-6 PUFA in Malignant and Normal Breast Tissue(At time of surgery)
- Number of Days to Establish Difference in Proliferation in Malignant Breast Tissue(At time of surgery)
- Number of Days to Establish Increased Apoptosis in Malignant Breast Tissue(At time of surgery)