Mechanism of Prostate Cancer Prevention by Lycopene
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Measurement of changes in percent free and total serum prostate-specific antigen (PSA) induced by lycopene
研究概览
简要总结
RATIONALE: Chemoprevention is the use of certain drugs or substances to keep cancer from forming, growing, or coming back. The use of lycopene, a substance found in tomatoes, may keep prostate cancer from forming.
PURPOSE: This randomized clinical trial is studying how well lycopene works in preventing prostate cancer in healthy participants.
详细描述
OBJECTIVES:
Primary
- Determine whether lycopene supplementation affects percent free and bound prostate-specific antigen (PSA) in healthy participants.
Secondary
- Determine whether lycopene reduces oxidative stress in these participants, as indicated by lipid peroxidation assay.
- Determine whether a 21-day washout period is sufficient to return lycopene, PSA, and lipid peroxidation products to baseline.
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
- Male
- 接受健康志愿者
- 是
入选标准
- •DISEASE CHARACTERISTICS:
- •Healthy participants
- •No existing prostate disease
- •PATIENT CHARACTERISTICS:
- •Able to supply blood and urine samples
- •Able to answer demographic and dietary recall questionnaires
- •No hospital inpatients
- •Not allergic to tomatoes or tomato products
- •Not abusing alcohol or non-prescribed drugs
- •No existing gastrointestinal disease or cancer
- •PRIOR CONCURRENT THERAPY:
- •At least 2 weeks since prior lycopene (in supplement form)
- •No concurrent participation in another clinical trial
排除标准
- 未提供
研究组 & 干预措施
Arm III
Participants receive oral placebo twice daily for 3 weeks.
干预措施: placebo (Other)
Arm II
Participants receive an oral tomato dietary supplement containing lycopene at a higher dose twice daily for 3 weeks.
干预措施: lycopene (Dietary Supplement)
Arm I
Participants receive an oral tomato dietary supplement containing lycopene twice daily for 3 weeks.
干预措施: lycopene (Dietary Supplement)
结局指标
主要结局
Measurement of changes in percent free and total serum prostate-specific antigen (PSA) induced by lycopene
次要结局
未报告次要终点