Clinical trial · Interventional
Selenium and Vitamin E in Preventing Cancer Progression and Recurrence in Patients With Early-Stage Bladder Cancer
Bladder Cancer Prognosis Programme (Incorporating SELENIB Trial) [TREATMENT]
NCT00553345CI-TRIAL-00013375unknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- 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. 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.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| chemoprevention | Procedure | — | UNRESOLVED |
| selenium | Drug | — | UNRESOLVED |
| vitamin E | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Recurrence-free interval
Secondary outcomes (6)
- measure
- Overall survival time
- measure
- Incidence of transitional cell carcinoma outside the bladder
- measure
- Incidence of all other malignancies clinically diagnosed
- measure
- Incidence of cardiovascular events
- measure
- Quality of life as assessed at each follow-up visit by the quality of life instruments EORTC QLQ-C30, QLQ-BLS24 and QLQ-BLM30
- measure
- Progression-free interval
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 dosageReferences
Publications (0)
Data not yet available
No reference posted for this study.