Phase III Randomized Chemoprevention Study of Selenium on the Recurrence of Non-invasive Bladder Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- KU Leuven
- 入组人数
- 276
- 试验地点
- 1
- 主要终点
- Effect of selenium in preventing the recurrence of bladder cancer
研究概览
简要总结
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of selenium may keep bladder cancer from growing or coming back. It is not yet known whether selenium is more effective than a placebo in preventing cancer recurrence in patients with bladder cancer.
PURPOSE: This randomized phase III trial is studying selenium to see how well it works compared with a placebo in preventing cancer recurrence in patients with bladder cancer.
详细描述
OBJECTIVES:
Primary
- To determine the effect of selenium, when administered with standard care, in preventing the recurrence of bladder cancer in patients with non-muscle-invasive transitional cell carcinoma of the bladder at risk for recurrence.
Secondary
- To determine the effect of selenium on the recurrence of bladder cancer, in terms of histological type, number, and size.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histopathologically confirmed non-muscle-invasive transitional cell carcinoma (TCC) of the bladder (< pT2 )
- •PATIENT CHARACTERISTICS:
- •Able to swallow pills
- •Not pregnant
- •Fertile patients must use effective contraception
- •No other malignancy within the past 5 years
- •No known hypersensitivity or adverse reactions to selenium
- •No other serious medical or psychiatric illness that would preclude giving informed consent
- •No condition that, in the opinion of the investigator, may interfere with the safety of the patient or the evaluation of the study objectives
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •More than 30 days since prior daily dietary supplements containing selenium
- •No other concurrent selenium (contained in individual supplements, antioxidant mix, or multivitamin) intake
- •No concurrent participation in another study involving a medical, surgical, nutritional, or lifestyle intervention
- •Concurrent participation in the follow-up phase of another study allowed
排除标准
- 未提供
研究组 & 干预措施
Arm I
Patients receive oral placebo daily in addition to standard care.
干预措施: placebo (Other)
Arm II
Patients receive oral selenium daily in addition to standard care.
干预措施: selenium (Dietary Supplement)
结局指标
主要结局
Effect of selenium in preventing the recurrence of bladder cancer
时间窗: 3 years
次要结局
- Effect of selenium on the progression of bladder cancer, in terms of histological type, number, and size(3 years)