NCT00402285已完成不适用
The Molecular Effects of Nutrition Supplements (MENS) Prostate Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Changes in Normal Prostate Tissue Gene Expression Between the Baseline and 3-month Biopsies in IGF -1 and COX -2
研究概览
简要总结
RATIONALE: The use of lycopene, a substance found in tomatoes, or omega-3 fatty acid nutritional supplements may keep cancer from growing in patients with prostate cancer.
PURPOSE: This randomized clinical trial is studying lycopene to see how well it works compared to omega-3 fatty acids or a placebo in treating patients with stage I or stage II prostate cancer.
详细描述
OBJECTIVES:
Primary
- Compare gene expression in normal prostate tissue (at baseline and after treatment) of patients with stage I or II adenocarcinoma of the prostate treated with lycopene vs omega-3 fatty acid nutritional supplements vs placebo.
Secondary
- Determine new candidate molecular targets for lycopene and omega-3 response pathways.
- Correlate baseline gene expression patterns, determined by cDNA array analysis, with self-reported dietary intake.
- Correlate gene expression patterns with progression or lack of progression at 12 months after study entry.
- Determine if lycopene or omega-3 supplements affect the incidence of tumor progression.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed adenocarcinoma of the prostate meeting the following criteria:
- •Newly diagnosed disease
- •Small cell acinar type
- •Gleason score ≤ 6 with no pattern 4 or 5 histology
- •Gleason pattern 4 seen as a microfocus (< 2 mm in length) allowed
- •Stage I-II (T1 or T2a) disease
- •Must have had an extended pattern biopsy (defined as 8+ cores) within the past 2 years
- •Patients meeting all of the eligibility criteria except for the aforementioned extended pattern biopsy within the past two years may enroll in the study if they have an extended pattern clinical biopsy scheduled no more than 6 weeks before beginning study treatment AND are willing to have an additional 4 biopsy cores
- •No more than 33% of biopsy cores positive
- •33% or more of biopsy cores positive due to microfoci of adenocarcinoma allowed
- •No more than 50% of the length of a tumor core involved by carcinoma
- •Watchful waiting planned as primary treatment strategy
- •Must have 3 serum prostate-specific antigen (PSA) level readings taken ≥ 2 weeks apart over the past year
- •PSA ≤ 10.0 ng/mL
- •PSA < 15 ng/mL in patients with benign prostatic hyperplasia or prostatitis allowed
- •PSA doubling time ≥ 3 months
- •PATIENT CHARACTERISTICS:
- •Life expectancy ≥ 3 months
- •ECOG performance status 0-2
- •No history of allergic reactions attributed to tomatoes, fish, soybean oil, gelatin capsules, or compounds of similar chemical or biologic composition to lycopene (carotenoids) or fish oil (omega-3 fatty acids)
- •No uncontrolled intercurrent illness including, but not limited to, the following:
- •Ongoing or active infection
- •Symptomatic congestive heart failure
- •Unstable angina pectoris
- •Cardiac arrhythmia
- •Psychiatric illness or social situations that would limit study compliance
- •PRIOR CONCURRENT THERAPY:
- •No prior or concurrent treatment for prostate cancer, including surgery, radiation, hormonal therapy (e.g., leuprolide acetate, bicalutamide, flutamide, goserelin, megestrol, nilutamide, diethylstilbestrol/estrogen), chemotherapy, PC-SPES, or investigational agents
- •More than 4 weeks since prior and no concurrent lycopene, fish oil (omega-3 fatty acids), or any other preparation intended to supplement levels of omega-3 unsaturated fatty acids
- •More than 4 weeks since prior and no concurrent finasteride, dutasteride, saw palmetto or any other herbal/nutritional preparation indicated to affect hormone levels
- •More than 1 month since prior nonsteroidal anti-inflammatory drugs (NSAIDs), cyclooxygenase-2 (COX-2) inhibitors, and/or aspirin for > 7 days duration
- •No concurrent NSAIDs, COX-2 inhibitors, or aspirin
排除标准
- 未提供
研究组 & 干预措施
lycopene supplement
Active Comparator
Two 15mg lycopene capsules daily for 3 months.
干预措施: lycopene supplement (Dietary Supplement)
placebo
Placebo Comparator
placebos for lycopene and fish oil.
干预措施: Placebo (Other)
fish oil supplement
Active Comparator
1g fish oil capsule daily for 3 months.
干预措施: fish oil supplement (Dietary Supplement)
结局指标
主要结局
Changes in Normal Prostate Tissue Gene Expression Between the Baseline and 3-month Biopsies in IGF -1 and COX -2
时间窗: baseline through 3 month
Comparisons of the change in deltaCT were between the placebo and Lycopene arms for IGF-1 and IGF-1R and between the placebo and fish oil arms for COX-2. Data in the table are mean changes in qRTPCR gene expression (normalized to GUSb) for IGF1, Cox2, and IGF1R.
次要结局
未报告次要终点
研究者
研究点 (1)
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