The Effect of Lycopene on DNA Damage in Human Prostate
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 主要终点
- Ability of prostatic tissue to accumulate doses of lycopene
研究概览
简要总结
RATIONALE: Chemoprevention is the use of certain substances to keep cancer from forming, growing, or coming back. Eating a diet high in lycopene, a substance found in tomatoes and tomato products, may keep cancer from forming or growing. Collecting and storing samples of blood from patients with cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.
PURPOSE: This randomized clinical trial is studying how well lycopene works in treating patients with prostate cancer or benign prostatic hyperplasia.
详细描述
OBJECTIVES:
- Assess the ability of prostatic tissue to accumulate doses of lycopene in patients with prostate cancer or benign prostate hyperplasia.
- Determine whether the steady state level of DNA oxidation in blood and prostate tissue is responsive to lycopene dosing.
- Investigate the effect of lycopene dosing on the lipid peroxidation marker malondialdehyde in serum.
- Assess the importance of measuring multiple DNA oxidation products as biomarkers of oxidative stress and its chemoprevention.
- Determine the significance of DNA oxidation products in blood as an indicator of oxidative stress in the prostate.
- Measure prostate and blood uptake of the chemoprevention agent lycopene.
OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral lycopene once daily for 3 weeks.
- Arm II: Patients receive oral placebo once daily for 3 weeks. In both arms, patients undergo biopsy to confirm diagnosis of prostate cancer or benign prostatic hyperplasia after 3 weeks of study therapy.
Blood samples are collected at baseline and before surgery for biomarker/laboratory studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 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
Ability of prostatic tissue to accumulate doses of lycopene
Responsiveness of steady state level of DNA oxidation in blood and prostate tissue to lycopene dosing
Effect of lycopene on lipid peroxidation marker malondialdehyde in serum
Importance of measuring multiple DNA oxidation products as biomarkers of oxidative stress and its chemoprevention
Significance of DNA oxidation products in blood as an indicator of oxidative stress in the prostate
Prostate and blood uptake of the chemoprevention agent lycopene
次要结局
未报告次要终点