UnknownPhase 3

Selenium and Vitamin E in Preventing Cancer Progression and Recurrence in Patients With Early-Stage Bladder Cancer

United Kingdom515 participantsStarted 2005-12

Plain-language summary

RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use of selenium and vitamin E may stop cancer from growing or coming back. PURPOSE: This randomized phase III trial is studying giving selenium together with vitamin E to see how well it works compared with a placebo in preventing cancer progression and recurrence in patients with early-stage bladder cancer.

Who can participate

Age range

18 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 (\< pT2) * Newly diagnosed disease * Able to be randomized within twelve months of diagnostic transurethral resection bladder tumor/biopsy * Must meet 1 of the following recurrence risk criteria: * Intermediate risk * Multiple G1 pTa (\> 1) * Solitary G1 pTa (≥ 3 cm) * G2 pTa * G1 pT1 * G2 pT1 (1 or 2 tumors) * High risk * G3 pTa * G3 pT1 * Cis * Multiple G2 pT1 (3 or more foci) * Low risk * Solitary G1 pTa \< 3 cm PATIENT CHARACTERISTICS: * Not pregnant or breast feeding * No HIV infection * No condition that, in the opinion of the local investigator, might interfere with the safety of the patient or evaluation of the trial objectives PRIOR CONCURRENT THERAPY: * No concurrent immunosuppressive therapy after organ transplantation * No concurrent cyclosporine * Those who currently use or have used selenium and/or vitamin E supplements will not be excluded, however, they must agree not to take supplements containing selenium and vitamin E above a pre-specified dosage

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

Recurrence-free interval

Trial details

NCT IDNCT00553345

SponsorUniversity of Birmingham

Sponsor typeOTHER

Study typeINTERVENTIONAL

View on ClinicalTrials.gov More Bladder Cancer trials