NCT00719030已完成不适用
A Randomized, Placebo-controlled, Pre-surgical Study of the Effects of Pomegranate Pills in Men With Prostate Cancer Prior to Radical Prostatectomy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 6
- 主要终点
- Pomegranate oxidative stress
研究概览
简要总结
The purpose of this study is to compare the effects of pomegranate polyphenol pills (POM-X) and a placebo (sugar pill) on prostatic oxidative stress. The placebo is a pill that looks like the POM-X pill but does not have an active ingredient.
详细描述
Subjects will receive POM-X or placebo pills daily for up to 4 weeks prior to undergoing radical prostatectomy for prostate cancer. Biomarkers in the blood, urine, and prostate tissue will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •Histologically confirmed adenocarcinoma of the prostate, without evidence of spread beyond to lymph nodes, bone, or visceral organs.
- •Radical prostatectomy scheduled at Duke or Johns Hopkins.
- •Initial prostate biopsy available for review with tumor involving 2 or more core biopsies based on pathologic review.
- •Age ≥ 18 years of age.
- •Willingness and ability to sign an informed consent document.
- •Agreement with complete abstinence from other commercially available pomegranate products during the course of the study.
- •No prior allergy to pomegranate dietary agents.
- •No significant medical or psychiatric condition that would make the patient a poor protocol candidate.
- •The patient agrees to stop taking dietary or vitamin supplements (lycopene, vitamin E, selenium, genistein) or herbal supplements (eg. saw palmetto) for 2-weeks prior to staring the study.
- •The patient is not taking LHRH agonists, androgen receptor blocking agents or finasteride, and has not undergone bilateral orchiectomy.
- •Patient has not received experimental medications within the past six months.
排除标准
- •Significant concomitant medical or psychiatric condition that, in the opinion of the investigator, would make the participant a poor protocol candidate.
- •Concomitant or antecedent hormonal therapy.
- •Known allergy to pomegranate juice.
- •Subjects unable or unwilling to comply with protocol requirements.
- •Evidence of metastatic disease on physical examination or on CT or bone scan.
- •Use of finasteride, dutasteride at any point during the study.
- •Clinically significant abnormal laboratory value >2X the upper limit of normal (2XULN).
结局指标
主要结局
Pomegranate oxidative stress
时间窗: On day of prostate surgery following 4 weeks of taking POM-X or placebo.
次要结局
未报告次要终点
研究者
研究点 (6)
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