Prostate Phytochemical & PUFA Intervention - a Phase I/II Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- serum prostate specific antigen
研究概览
简要总结
We will study the effect of dietary intervention in patients with prostate cancer. Outcomes include serum PSA kinetics, as well as biomarkers of inflammation, antioxidant status, oxidative stress and oxidative damage in blood cells, plasma, urine and prostate tissues
详细描述
A total of 102 patients with localized prostate cancer will be included in the study. A the time of inclusion, the participants will be randomized to three groups.
The intervention groups includes; control group, tomato group and multi-diet group. The intervention period is three week and will be completed before prostatectomy or radiation therapy.
Biomarkers og inflammation includes: acute phase proteins, cytokines, chemokines and other inflammatory mediators. Biomarker of antioxidant status includes vitamin C, vitamin E, glutathione, carotenoids, total antioxidant capacity and total phenolics. Oxidative stress markers includes; malondialdehyde, isoprostanes, 8-hydroxy-deoxyguanosine, oxidized vitamin C, total lipidperoxides (d-ROM) and protein carbonyls.
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
- Single (Outcomes Assessor)
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Adenoarcinoma (as confirmed by histology)
- •pN0/NXM0 (TNM/UICC 2002) and at least one negative prognosis factor for HDR-BT or low risk profile with the use of radical prostatectomy.
- •Serum PSA< 20 ng/mL, and Gleason score =>6 or T1c- T3a, prostate volume < 60mL
- •Performance status 0-1
- •Normal WBC and thromocytes, Hb >11g/dl
排除标准
- •No previous endocrine treatment
- •Life expectancy > 5 år
- •No possible co-morbidity (CVD, COPD, diabetes type I, vasculatory syndromes or inflammatory diseases that may affect quality of life and radiation therapy)
- •Urinary retention, incontinens or IPPS score <12
结局指标
主要结局
serum prostate specific antigen
时间窗: Baseline, after intervention, follow-up
次要结局
- oxidative damage biomarkers in blood, tissue and urine(Baseline, after intervention, follow-up)
- oxidative stress biomarkers in blood, tissue and urine(Baseline, after intervention, follow-up)
- Apoptose markers in prostate tissue(Baseline, after intervention, follow-up)
- antioxidant status biomarkers in blood, tissue and urine(Baseline, after intervention, follow-up)
- inflammation biomarkers in blood, tissue and urine(Baseline, after intervention, follow-up)
- DNA microarrays in blood cells and prostate tissue(Baseline, after intervention, follow-up)
研究者
Rune Blomhoff
Professor
University of Oslo