Selenium in Preventing Cancer Recurrence in Patients With Bladder Cancer (NCT00729287) | Clinical Trial Compass
CompletedPhase 3
Selenium in Preventing Cancer Recurrence in Patients With Bladder Cancer
Belgium276 participantsStarted 2009-09
Plain-language summary
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.
Who can participate
Age range
18 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Effect of selenium in preventing the recurrence of bladder cancer