Comparison of Duration of Treatment Interruption With or Without Curcumin During the Off Treatment Periods in Patients With Prostate Cancer Undergoing Intermittent Androgen Deprivation Therapy : a Randomized, Double Blind, Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 107
- 主要终点
- Duration of treatment interruption with or without curcumin
研究概览
简要总结
This was a placebo-controlled, double-blind, randomized trial designed with the aim of establishing whether curcumin influenced the duration of treatment interruption and rate of prostatic specific antigen(PSA) progression, compared with placebo among men with prostate cancer receiving intermittent androgen deprivation therapy.
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
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •patients diagnosed with prostate cancer in biopsy
- •among patients with biochemical recurrence after treatment(radical prostatectomy, radiation therapy, focal therapy, etc.) for localized prostate cancer or metastatic prostate cancer at the time of diagnosis, who received intermittent androgen deprivation therapy(IAD)
- •patients who off-treatment for the first time by receiving androgen deprivation therapy(ADT) for more than 6 months and PSA nadir remained stable for more than 3 months
排除标准
- •previous history of IAD
- •patient with other serious or ongoing medical or psychiatric disease other than prostate cancer
- •hypersensitivity or suspicious of curcumin
- •history of taking health supplements containing curcumin for prostate cancer treatment before 6 months of clinical trial participation
研究组 & 干预措施
control
The control group Take a placebo containing lactose and vitamin B2. Reddish brown capsules with the same shape as curcumin.
干预措施: Placebo (Dietary Supplement)
curcumin
Curcumin extracted from curcuma longa linn.
- formulation : curcumin powder 240mg/capsule
- general name : Diferuloylmethane
Taking curcumin 3 times a day(1,440mg/day) for 6 months at the first off treatment in patients with prostate cancer receiving intermittent androgen deprivation therapy
干预措施: curcumin (Dietary Supplement)
结局指标
主要结局
Duration of treatment interruption with or without curcumin
时间窗: up to 42 months
To determine whether the period from the first interruption of the androgen deprivation therapy to the time when androgen deprivation therapy needs to be retreated differ between curcumin group and placebo group
次要结局
- Mean change in PSA(ng/ml) from baseline between curcumin group versus placebo(0,1,2,3,4,5,6,12,18,30,42 months)
- Mean change in testosterone(ng/ml) from baseline between curcumin group versus(0,1,2,3,4,5,6,12,18,30,42 months)
- Adverse events(0,1,2,3,4,5,6,12,18,30,42 months)