Lycopene or Green Tea a Feasibility Study in Men at Risk of Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Serum lycopene and epigallocatechin-3-gallate (green tea) levels at 6 months following randomization
研究概览
简要总结
RATIONALE: Lycopene and green tea may stop or delay the development of recurrent prostate cancer in patients has been treated for prostate cancer. It is not yet known whether lycopene or green tea may be more effective in preventing prostate cancer.
PURPOSE: This randomized phase II trial is studying lycopene to see how well it works compared with green tea in preventing prostate cancer in patients previously enrolled in the ProtecT trial
详细描述
OBJECTIVES:
Primary
- To assess serum lycopene and epigallocatechin-3-gallate (green tea) levels at 6 months following randomization in patients with prostate cancer previously enrolled on ProtecT
Secondary
- To evaluate trial recruitment and randomization rates of patients treated with this regimen.
- To evaluate intervention tolerability in patients treated with this regimen.
- To evaluate compliance of patients treated with this regimen.
- To evaluate trial retention of patients treated with this regimen.
- To assess PSA values in patients treated with this regimen.
- To evaluate dietary compliance with recommendations of patients treated with this regimen.
- To assess weight and body mass index of patients treated with this regimen.
- To evaluate attitudes and views of men and their spouses about dietary modification and participation in long-term study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 69 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •PSA level 2.0-2.95 ng/mL OR PSA level ≥ 3.0 ng/mL with a negative biopsy No major comorbidities No other cancers or prior prostate malignancy No history of allergic reactions to green tea or lycopene-containing products, including guava or watermelon
排除标准
- •No concurrent finasteride or dutasteride
研究组 & 干预措施
Green tea drink
Green tea drink
干预措施: Green tea drink (Behavioral)
Green tea capsules
Green tea capsules
干预措施: green tea capsules (Dietary Supplement)
Green tea placebo capsules
Green tea placebo capsules
干预措施: Green tea placebo capsules (Other)
Lycopene capsules
Lycopene capsules
干预措施: Lycopene capsules (Dietary Supplement)
Lycopene placebo capsules
Lycopene placebo capsules
干预措施: Lycopene placebo capsules (Other)
Tomato rich diet
Tomato rich diet
干预措施: Tomato rich diet (Other)
结局指标
主要结局
Serum lycopene and epigallocatechin-3-gallate (green tea) levels at 6 months following randomization
时间窗: 6 months
次要结局
- Compliance (returned tablet counts and self-reported counts at 6 months)(6 months)
- Attitudes and views of men and their spouses about dietary modification and participation in long-term study (qualitative interviews conducted throughout the study)(6 months)
- Urinary symptoms as measured by the ICSmaleSF questionnaire (including voiding and incontinence scores, nocturia, frequency, and urinary-specific quality-of-life care data sources)(6 months)
- PSA values at baseline and at 6 months(6 months)
- Trial recruitment and randomization rates at each stage of the study(6 months)
- Intervention tolerability (adverse event reporting during the six months of follow-up)(6 months)
- Trial retention (participants completing 6-month follow-up and questionnaires)(6 months)
- Dietary compliance with recommendations (dietary questionnaire completed at 6 months and participant data reporting dietary change)(6 months)
- Weight and body mass index at 1 and 6 months(6 months)
- Blood pressure at 1 and 6 months(6 months)
- Anxiety, depression, and psychological state as measured by the Hospital Anxiety and Depression Scale and the Profile of Moods States(6 months)
研究者
Dr Athene Lane
Study Coordinator and Senior Research Fellow
University of Bristol