Prostate Cancer: Impact Of Fat And Flaxseed - Modified Diets
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 161
- 试验地点
- 6
- 主要终点
- Prostatic Carcinoma Proliferation Rate by MIB-1 assay at time of prostatectomy
研究概览
简要总结
RATIONALE: A diet that is low in fat and/or high in flaxseed may slow or prevent disease progression of prostate cancer.
PURPOSE: Randomized phase II trial to study the effectiveness of a diet that is low in fat and/or high in flaxseed in slowing or preventing disease progression in patients who have newly diagnosed prostate cancer.
详细描述
OBJECTIVES:
- Compare tumor proliferation in patients with newly diagnosed prostate cancer eating fat- and/or flaxseed-modified diets.
- Compare differences in histopathological markers associated with prostate cancer (rates of apoptosis, extent of high-grade prostatic intraepithelial neoplasia) among patients in these diet groups.
- Compare changes in serum prostate specific antigen among patients in these diet groups.
- Compare changes in hormone-related factors (total serum testosterone and free androgen index, insulin-like growth factor [IGF], and IGF-binding protein-3) among patients in these diet groups.
- Compare the effects of diet on nutritional biomarkers (levels of lignans in the urine and ejaculate, fatty acid profiles of erythrocytes and prostatic tissue) in these patients.
- Determine associations between dietary modification and changes in dietary biomarkers, hormonal intermediates, and study endpoints in these patients.
OUTLINE: This is a randomized study. Patients are stratified according to Gleason score (less than 7 vs at least 7) and race (black vs non-black). Patients are randomized to 1 of 4 diet groups.
- Arm I (Flaxseed-supplemented diet): Patients are instructed to incorporate ground flaxseed into their daily diets.
- Arm II (Low-fat diet): Patients are instructed on ways to achieve a diet with no greater than 20% of total energy from dietary fat.
- Arm III (Flaxseed-supplemented, low-fat diet): Patients are instructed as in arm I and arm II.
- Arm IV (Control diet): Patients are contacted weekly, but do not receive dietary counseling until after surgery.
All patients ingest the diets for at least 3 weeks and complete diet diaries until surgery. After surgery, all patients receive dietary counseling.
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 120 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Prostatic Carcinoma Proliferation Rate by MIB-1 assay at time of prostatectomy
次要结局
- Prostatic Carcinoma Apoptotic Index by TUNEL assay at time of prostatectomy
- Total testosterone, sex hormone binding globulin, insulin-like growth factor (IGF), and IGF-binding protein-3, total cholesterol, and low-density lipoprotein cholesterol by ELISA assays at baseline and follow-up
- Prostate-specific antigen by Hybritech assay at baseline and follow-up