A Randomized, Double-Blind Study of Combination Vitamin E, Selenium and Lycopene vs. Placebo in Men Undergoing Radical Prostatectomy for Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- To determine the impact of combination Vitamin E, Selenium and Lycopene on prostate tumor size and to study certain markers in blood and prostate tissue which affect prostate tumor growth or shrinkage.
研究概览
简要总结
The purpose of this study is to see if an intervention of antioxidants(vitamin E, selenium and lycopene) can change (reduce) prostate tumor size and alter certain markers that can affect tumor growth and prostate cancer aggressiveness.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of a Gleason score > or = to 7 adenocarcinoma of the prostate
- •At least 30% of one core involved
- •Radical prostatectomy planned
- •Willingness to discontinue use of supplements at least 4 weeks prior to study intervention (for subjects using vitamin E, selenium or lycopene at time of consent)
- •ability and willingness to consume study intervention for 6 - 8 weeks prior to radical prostatectomy.
排除标准
- •Previous treatment for prostate cancer
- •Current use of finasteride or dutasteride
研究组 & 干预措施
1
This group of men will be on active treatment (antioxidants)for 6-8 weeks prior to their radical prostatectomy.
干预措施: Lycopene, Vitamin D3, Selenium, Green Tea Extract, Vitamin E (Dietary Supplement)
2
This group of men will be on placebo for 6-8 weeks prior to their radical prostatectomy.
干预措施: Placebo (Drug)
结局指标
主要结局
To determine the impact of combination Vitamin E, Selenium and Lycopene on prostate tumor size and to study certain markers in blood and prostate tissue which affect prostate tumor growth or shrinkage.
时间窗: Blood samples will be collected prior to intervention and 8 weeks later , prior to surgery. Prostate tissue will be harvested at time of surgery, after the prostate has been removed.
次要结局
未报告次要终点