An Investigative, Randomized, Open, Pilot Study to Assess the Tolerability, Safety and Efficacy of HAcid/CS Intravesical Instillations Plus an Oral Combination of Curcumin,Quercetin, HA and CS in Prevention of Radiation Induced Cystitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 7
- 主要终点
- Rate of patients
研究概览
简要总结
The study is randomized and it will be conducted in the field of routine clinical practice. A total of 100 consecutive patients planned to receive radiotherapy for prostate cancer will be enrolled.
The patients will enter the study as controls (50 patients that won't receive any experimental IMP) or as treated-group (50 patients that will be also treated with the experimental IMPs, Ialuril® and Ialuril® Soft Gels) according to a predefined, centre-specific randomization.
详细描述
Radiotherapy will last for 6 weeks. During planning of treatment, regimen and average dose to the whole bladder will be recorded to assess the impact of EBRT on urinary symptoms.
The treated-group will receive also intravesical Ialuril® weekly for 6 weeks (in the 24 hours before every radiation therapy weekly schedule), plus oral treatment with Ialuril® Soft Gels capsules (1 capsule twice a day after meals, at a distance of 12 hours, for 12 weeks).
The control-group will receive radiotherapy only for 6 weeks.
The Primary Objective is to assess the tolerability and safety of HA-CS intravesical instillations (Ialuril®) plus an oral combination of curcumin, quercetin, HA and CS (Ialuril® Soft Gels) in male patients undergoing radiotherapy for prostate cancer The efficacy of the treatment will be evaluated at the end of the study once received all the crfs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •Male patients planned to receive primary radiotherapy for prostate cancer.
排除标准
- •Female patients
- •Patients with a life expectancy of less than 24 months
- •with radiological confirmed metastasis
- •with documented urethral strictures
- •undergoing chemotherapy
- •who received brachytherapy
- •who received chemo-radiotherapy for prostate cancer in the past
- •previously treated with Bacillus Calmette-Guerin (BCG)
- •with post-void residual (PVR) > 200ml
- •with clinical evidence of bladder calculi
- •with neurogenic bladder or neurologic disease at risk for neurogenic bladder
- •suffering from any lower urinary infections (UTIs, tuberculosis)
- •with unstable cardiovascular disease
- •with Congestive Heart Failure (CHF)
- •with current nitrate use
- •with current anticoagulants use (i.e. warfarin, heparin, etc.)
- •with clinically significant hepatobiliary or renal disease
- •with history of significant CNS injuries within 6 months
- •with any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial
结局指标
主要结局
Rate of patients
时间窗: 12 months
The rate of patients who stopped treatment with intravesical or oral Ialuril due to intollerance or adverse events
次要结局
- comparative analysis of score of QOL(12 months)
- comparative analysis of score between the two groups through EPIC(12 months)
- comparative analysis of score between the two groups through ICIQ(12 months)
- comparative analysis of score between the two groups through IPSS(12 months)