Effects of Brewed Green and Black Tea on Inflammation, Apoptosis and Oxidation in Men With Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 113
- 试验地点
- 4
- 主要终点
- Effect of Green Tea (GT) and Black Tea (BT) Consumption on Percentage of Cells With Positive Staining for Apoptosis, Proliferation, Oxidation, and Inflammation in Malignant Radical Prostatectomy Tissue Compared to Water Control Using Immunohistochemistry.
研究概览
简要总结
RATIONALE: Green tea contains ingredients that may prevent or slow the growth of certain cancers. It is not yet known whether green tea is more effective than black tea or water in treating prostate cancer.
PURPOSE: This randomized phase II trial is studying green tea to see how well it works compared with black tea and water in treating patients with prostate cancer undergoing surgery.
详细描述
OBJECTIVES:
- to determine the effect of GT and BT consumption on apoptosis (TUNEL, ratio Bax:Bcl-2), proliferation, oxidation, and inflammation in malignant radical prostatectomy tissue compared to water control using immunohistochemistry.
- to examine levels of tea polyphenols and methylated tea polyphenol metabolites in fresh frozen radical prostatectomy tissue and urine, urinary oxidative DNA damage (8OHdG) and serum prostate-specific antigen (PSA) levels.
OUTLINE: This is a multicenter, randomized study. Patients are randomized to 1 of 3 treatment arms.
- Arm I: Patients receive 6 cups of green tea daily for 2-8 weeks in the absence of unacceptable toxicity.
- Arm II: Patients receive 6 cups of water daily for 2-8 weeks in the absence of unacceptable toxicity.
- Arm III: Patients receive 6 cups of decaffeinated black tea daily for 2-8 weeks in the absence of unacceptable toxicity.
Patients undergo radical prostatectomy.
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
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •subject consents to participate in the trial.
- •subject is 40-75 years of age and has a diagnosis of adenocarcinoma of the prostate.
- •Scheduled to undergo radical prostatectomy.
- •The subject agrees to stop consumption of tea or tea-containing products throughout the entire intervention period except for the tea provided during study intervention.
- •The subject agrees to stop consumption of dietary or vitamin supplements (e.g., lycopene, Vitamin E, selenium, genistein) or herbal supplements (e.g., saw palmetto, PC-SPES)
排除标准
- •history of hepatitis or liver dysfunction
- •ongoing alcohol abuse
- •significant medical or psychiatric conditions that would make the patient a poor protocol candidate
- •prior sensitivity or allergic reaction to tea, tea products, or tea supplements
- •allergy or sensitivity to multiple food items or nutritional supplements
- •concurrent luteinizing hormone-releasing hormone agonists, androgen receptor blocking agents, or finasteride
- •prior bilateral orchiectomy
结局指标
主要结局
Effect of Green Tea (GT) and Black Tea (BT) Consumption on Percentage of Cells With Positive Staining for Apoptosis, Proliferation, Oxidation, and Inflammation in Malignant Radical Prostatectomy Tissue Compared to Water Control Using Immunohistochemistry.
时间窗: 6 weeks
To determine the effect of Green Tea and Black Tea consumption on Prostate cancer tissue by examining programmed cell death, cell proliferation, cell oxidation, and cellular inflammation in that malignant radical prostatectomy tissue compared to water control using immunohistochemistry.
次要结局
- Concentration of Tea Polyphenols, Their Metabolites, and Colonic Metabolites in Prostate Tissue(6 weeks)
- Concentration of Tea Polyphenols and Methyl-metabolites in Urine After the Consumption of Green Tea (GT) and Black Tea (BT).(6 weeks)
- Prostate Specific Antigen (PSA) After the Consumption of Green Tea (GT) and Black Tea (BT).(6 weeks)