Effects of Bassica or Indole-3-Carbinol on Prostatectomy Patients With PSA Recurrence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 主要终点
- Adverse events
研究概览
简要总结
RATIONALE: Eating a diet high in vegetables may lower the risk of some types of cancer. Brassica vegetables (such as cabbages, kale, broccoli, Brussels sprouts, and cauliflower) and indole-3-carbinol (a substance found in cruciferous vegetables) may help lower the risk of prostate cancer recurrence.
PURPOSE: This randomized clinical trial is studying the side effects and how well Brassica vegetables work compared with indole-3-carbinol in treating patients with PSA recurrence after surgery for prostate cancer.
详细描述
OBJECTIVES:
- Determine the feasibility of Brassica vegetable intake and indole-3-carbinol supplement use in patients with prostate cancer with prostate-specific antigen (PSA) recurrence after prostatectomy.
- Identify adverse events in these patients.
- Quantify the effects of each intervention on PSA in these patients.
OUTLINE: Patients are stratified by pretreatment prostat-specific antigen (PSA) growth rate (low [0.00-0.15] vs medium [0.16-0.30] vs high [> 0.30]). They are randomized to 1 of 3 treatment arms, and randomization status to arms II and III is double-blinded.
- Arm I (Brassica vegetables): Patients consume Brassica vegetables at least 2 servings (½ cup/serving) daily for 6 months. Patients meet one-on-one with the study dietician, and are instructed on the potential health benefits of Brassica vegetables and purchase and preparation of the vegetables. Patients undergo telephone counseling periodically in months 1-5, to monitor their progress and identify barriers to adherence and to develop solutions to overcome these barriers.
- Arm II (Placebo): Patients receive oral placebo once daily for 6 months.
- Arm III (Indole-3-carbinol supplement): Patients receive oral indole-3-carbinol supplement (capsules) once daily for 6 months.
Blood and urine samples (for urinary isothiocyanate levels) are collected at baseline and at 2, 4, and 6 months. Patients complete questionnaires assessing demographics, family cancer history, and health history and measuring changes in medications, lifestyle, adverse events, and health. Medical records are reviewed for prostate cancer-related information, surgical dates, dose and type of radiation, and PSA history.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of prostate cancer with PSA recurrence after prostatectomy
- •PSA recurrence is defined as two consecutively rising PSA tests ≥ 8 weeks since the post-surgical nadir, with a minimal interval of 2 weeks between tests and at least 1 PSA test > 0.4 ng/mL
排除标准
- •Life expectancy ≥ 9 months
- •No predictors of poor adherence (e.g., erratic life-style, mental incompetence)
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •No other concurrent Brassica vegetable consumption > 1 serving/day
- •No other concurrent indole-3-carbinol supplements
- •No endocrine or radiation treatment within past 4 weeks
- •No other scheduled treatment during study intervention
- •Concurrent prescription medications during the trial allowed
- •At least 2 weeks since prior and no concurrent vitamin or herbal supplement use
- •Patients refusing to stop non-study supplements will be asked to maintain constant use
研究组 & 干预措施
Brassica Vegetables Diet Intervention
干预措施: counseling intervention (Other)
Brassica Vegetables Diet Intervention
干预措施: behavioral dietary intervention (Behavioral)
Brassica Vegetables Diet Intervention
干预措施: Brassica vegetable (Dietary Supplement)
Brassica Vegetables Diet Intervention
干预措施: indole-3-carbinol (Drug)
Brassica Vegetables Diet Intervention
干预措施: medical chart review (Other)
Brassica Vegetables Diet Intervention
干预措施: questionnaire administration (Other)
Brassica Vegetables Diet Intervention
干预措施: adjuvant therapy (Procedure)
Pill
干预措施: indole-3-carbinol (Drug)
Pill
干预措施: counseling intervention (Other)
Pill
干预措施: medical chart review (Other)
Pill
干预措施: questionnaire administration (Other)
Pill
干预措施: adjuvant therapy (Procedure)
结局指标
主要结局
Adverse events
时间窗: will be measured at 2-Months, 4-Months, and 6-Months after Baseline start for the diet intervention
Effects of intervention on prostate-specific antigen
时间窗: Not noted
Feasibility of Brassica vegetable intake and indole-3-carbinol supplementation
时间窗: will be measured at 2-Months, 4-Months, and 6-Months after Baseline start for the diet intervention
次要结局
未报告次要终点
研究者
Jay Fowke
Associate Professor
Vanderbilt University