Catechins and Omega-3 Fatty Acids Impact on Fatty Acid Synthase Activity in the Prostate: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 89
- 试验地点
- 3
- 主要终点
- Cell Proliferation by Ki67-immunohistochemistry at Pre- and Post-intervention
研究概览
简要总结
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of fish oil and/or green tea may prevent prostate cancer.
PURPOSE: This randomized clinical trial is studying how well a fish oil and/or green tea supplement works in preventing prostate cancer in patients with prostatic intraepithelial neoplasia or who are at risk for developing prostate cancer.
详细描述
OBJECTIVES:
- Determine the cancer preventing effects of fish oil supplementation and green tea extract use on markers of alteration in lipid metabolism in prostate tissue samples.
OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to age (under 65 vs 65 and over). Patients are randomized to 1 of 4 treatment arms.
- Arm I: Patients receive oral fish oil three times daily and oral green tea extract twice daily.
- Arm II: Patients receive an oil placebo three times daily and oral green tea extract twice daily.
- Arm III: Patients receive oral fish oil three times daily and a placebo twice daily.
- Arm IV: Patients receive an oil placebo three times daily and another placebo twice daily.
Treatment in one of the above-listed arms continues for up to 20 weeks in the absence of disease progression or unacceptable toxicity.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 120 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Clinician recommends repeat biopsy of the prostate ("Repeat" is defined as any recommended biopsy of the prostate subsequent to an earlier biopsy of the prostate)
排除标准
- •Definitive invasive prostate cancer on initial biopsy
- •Significant active medical illness that in the opinion of the clinician would preclude protocol treatment.
- •History of ventricular tachycardia or ventricular fibrillation
- •Subject reported use of fish oil (greater than 1 gram per day) or green tea supplement within 30 days before Day 1 of study treatment
- •Subject reported use of fish oil ≤ 1 gram per day and unwilling to discontinue use for the duration of the trial
- •Use of warfarin or need for therapeutic anticoagulation at time of biopsy or at anytime during the course of the trial.
- •Subject reported allergy or sensitivity to fish oil, olive oil or green tea
- •Subject reported history of hemophilia, van Willebrands disease or other bleeding disorder, except when the subject is evaluated by a hematologist who determines that fish oil supplementation is not contraindicated.
- •Total bilirubin greater than institutional upper limit of normal
- •Concurrent high risk study participation
研究组 & 干预措施
Arm I (FO, GT catechin extract)
Patients receive oral fish oil (FO) 3/day and oral green tea (GT) extract 2/day
干预措施: green tea catechin extract (Dietary Supplement)
ArmII (FO placebo, GT catechin extract)
Patients receive a fish oil (FO) placebo 3/day and oral green tea (GT) extract 2/day
干预措施: green tea catechin extract (Dietary Supplement)
ArmII (FO placebo, GT catechin extract)
Patients receive a fish oil (FO) placebo 3/day and oral green tea (GT) extract 2/day
干预措施: placebo (Other)
Arm III (FO, GT placebo)
Patients receive oral fish oil (FO) 3/day and a placebo mimicking green tea (GT) catechins 2/day
干预措施: placebo (Other)
Arm IV (FO placebo, GT placebo)
Patients receive a fish oil (FO) placebo mimicking fish oil 3/day and another placebo mimicking green tea (GT) catechins 2/day
干预措施: placebo (Other)
Arm III (FO, GT placebo)
Patients receive oral fish oil (FO) 3/day and a placebo mimicking green tea (GT) catechins 2/day
干预措施: fish oil (Dietary Supplement)
Arm I (FO, GT catechin extract)
Patients receive oral fish oil (FO) 3/day and oral green tea (GT) extract 2/day
干预措施: fish oil (Dietary Supplement)
结局指标
主要结局
Cell Proliferation by Ki67-immunohistochemistry at Pre- and Post-intervention
时间窗: End of study
Cell Proliferation by Ki67 is calculated as the percent stained by immunohistochemistry. Ki-67 values were log-transformed because the original distribution was skewed. Analysis was done on log-base2 transformed values.
Fatty Acid Synthase Expression by Immunohistochemistry at Pre- and Post-intervention (FAS Summary Score)
时间窗: Baseline (pre-intervention) and end of study (time to surgery for those with malignant findings or up to 8 weeks for those with benign biopsies, post-intervention)
Sections of paraffin-embedded prostate biopsy tissue were stained for fatty acid synthase (FAS) expression. The FAS Summary Score was calculated as the product of percent stained (1=0-25%, 2=25-50%, 3=51-75%, 4=76-100%) and stain intensity (0-3) by immunohistochemistry. The range of the product is 0-300.
次要结局
未报告次要终点
研究者
Jackie Shannon
Principal Investigator
OHSU Knight Cancer Institute