Selenium and Vitamin E in Preventing Cancer Progression and Recurrence in Patients With Early-Sta… (NCT00553345) | Clinical Trial Compass
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 range18 Years
SexALL
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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