Radiation Therapy With or Without Curcumin Supplement in Treating Patients With Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Biochemical or clinical progression-free survival
研究概览
简要总结
Prostate cancer is the second most incident cancer among male population worldwide. Radiation therapy by itself or along with surgery and chemotherapy are the main treatments for prostate cancer however prostate cancer cells are only modestly responsive or even unresponsive to the cytotoxic effects of radiotherapy. Recently some in vitro and in vivo studies showed radiosensitizing and radioprotective effects for curcumin. No clinical trial has been done in this area and it is not yet known whether radiation therapy is more effective with or without curcumin supplements in treating patients with prostate cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed adenocarcinoma of the prostate
- •Age range of 50-80
- •ECOG performance status 0-1
- •Life expectancy > 5 years
- •Must be enrolled in a social security program
- •No other cancer, except basal cell skin cancer, that has been treated or relapsed within the past 5 years
- •No severe uncontrolled hypertension (systolic BP ≥ 160 mm Hg or diastolic BP ≥ 90 mm Hg)
- •No contraindication to luteinizing hormone-releasing hormone agonists
- •No contraindication to pelvic irradiation (e.g., scleroderma, chronic inflammatory gastrointestinal disease)
- •No hip prosthesis
- •Must not be deprived of liberty or under guardianship
- •No geographical, social, or psychological reasons that would preclude follow up
排除标准
- •Clinical stage T3 or T4
- •Gleason score ≥ 8
- •Serum PSA ≥ 20 ng/mL and ≤ 100 ng/mL
- •other prior surgery for prostate cancer
- •concurrent participation in another clinical trial which would require approval upon entry to this trial
- •Gastrointestinal disorders such as IBD, reflux and peptic ulcers
- •Any adverse reaction to curcumin
结局指标
主要结局
Biochemical or clinical progression-free survival
时间窗: 1 year
To assess this outcome the results of magnetic resonance spectroscopy (MRS)will be compared between the 2 groups 1 week before radiation therapy and 3 months after radiotherapy completion. Also prostate specific antigen (PSA)rebound will be compared between the 2 groups after 1 year. Side effects of treatment during 1 year after treatment completion will be compared between the 2 groups using questionnaires and physical examination
次要结局
- Inflammatory factors (tumor necrosis factor alpha (TNF-alpha), Interleukin 1 beta (IL1-beta)and Interleukin 6 (ILl-6))(5 monthes)
- cycloxygenase 2 (COX2)(5 months)
- Nuclear factor KB (NF-ΚB)(5 months)
- Sexual dysfunction score(1 year)
- Antioxidant enzymes (Catalase, super oxide dismutase (SOD), glutathione-S- transferase (GST), glutathione peroxidase (GPX))(5 months)
- Quality of life(1 year)
- C-reactive protein (hs-CRP)(5 months)
研究者
Reza Rastmanesh
Dr.
Shahid Beheshti University of Medical Sciences