Phase II Study of Nanocurcumin Versus Placebo for Patients Undergoing Radiotherapy for Prostate Cancer
试验速览
- 阶段
- 2 期
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Proctitis [assessed using Common terminology criteria for adverse events (CTCAE)]
研究概览
简要总结
There is a growing body of evidence exploring the role of curcumin as a radioprotector against radiation-induced injury in normal tissues as well as a radiosensitizer in tumor cells. The aim of this study is to determine the efficacy of oral nanocurcumin in prostate cancer patients undergoing radiotherapy.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed adenocarcinoma of the prostate
- •Candidate for External Beam Radiotherapy
- •ECOG performance status 0-2
排除标准
- •Patients with Metastatic Prostate Cancer
- •Patients with Kidney & Liver dysfunction
- •Gastrointestinal disorders such as IBD, reflux and peptic ulcers
- •Any adverse reaction to curcumin
研究组 & 干预措施
Curcumin plus RT
120mg/day nanocurcumin during RT course
干预措施: Curcumin (Drug)
Curcumin plus RT
120mg/day nanocurcumin during RT course
干预措施: RT (Radiation)
Placebo plus RT
120mg/day placebo of nanocurcumin during RT course
干预措施: RT (Radiation)
Placebo plus RT
120mg/day placebo of nanocurcumin during RT course
干预措施: Placebo (Drug)
结局指标
主要结局
Proctitis [assessed using Common terminology criteria for adverse events (CTCAE)]
时间窗: 90 days
Proctitis as assessed using Common terminology criteria for adverse events (CTCAE)
次要结局
- Hematologic Toxicity(90 days)
- Biochemical progression-free survival (b-PFS)(5-years)
- Treatment Response(3 months after treatment termination)
- Cystitis [assessed using CTCAE Grading Criteria](90 days)
研究者
Bahram Mofid
Professor
Shahid Beheshti University of Medical Sciences