Clinical trial · Interventional
Selenium in Preventing Cancer Recurrence in Patients With Bladder Cancer
Phase III Randomized Chemoprevention Study of Selenium on the Recurrence of Non-invasive Bladder Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| placebo | Other | — | UNRESOLVED |
| selenium | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Arm I
- description
- Patients receive oral placebo daily in addition to standard care.
- interventionNames
- Other: placebo
- type
- EXPERIMENTAL
- label
- Arm II
- description
- Patients receive oral selenium daily in addition to standard care.
- interventionNames
- Dietary Supplement: selenium
Primary outcomes (1)
- measure
- Effect of selenium in preventing the recurrence of bladder cancer
- timeFrame
- 3 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDGoossens ME, Buntinx F, Joniau S, Ackaert K, Ameye F, Billiet I, Braeckman J, Breugelmans A, Darras J, Dilen K, Goeman L, Kellen E, Tombal B, Van Bruwaene S, Van Cleyenbreuge B, Van der Aa F, Vekemans K, Van Poppel H, Zeegers MP. Designing the selenium and bladder cancer trial (SELEBLAT), a phase lll randomized chemoprevention study with selenium on recurrence of bladder cancer in Belgium. BMC Urol. 2012 Mar 21;12:8. doi: 10.1186/1471-2490-12-8. PMID 22436453