Bladder cancer MedDRA version: 9.1 Level: LLT Classification code 10005014 Term: Bladder carcinoma MedDRA version: 9.1 Level: LLT Classification code 10005003 Term: Bladder cancer MedDRA version: 9.1 Level: LLT Classification code 10005004 Term: Bladder cancer NOS
Conditions
Interventions
Trade Name: Selenium
Product Name: selenium
Pharmaceutical Form: Coated tablet
CAS Number: 7782492
Other descriptive name: SELENIUM
Concentration unit: µg microgram(s)
Concentration type: up to
Concen
Sponsors
ACHG-K.U.Leuven
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Gender: male or female ? Members of all races and ethnic groups are eligible for this trial. ? Age: =18 ? Histopathologically confirmed non-muscle-invasive transitional cell carcinoma ( 1) ? Solitary G1 pTa (= 3 cm) ? G2 pTa ? G1 pT1 ? G2 pT1 (1 or 2 tumours) o High risk ? G3 pTa ? G3 pT1 ? Cis ? Multiple G2 pT1 (3 or more foci) ? Must be able to swallow pills ? Must agree not to take supplements containing selenium apart from the trial medication ? Fertile female patients must use effective contraception ? Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: ? Solitary grade 1, pTa < 3 cm or stage pT2 and above ? Residual tumors: patients with a recurrence within a period of 3 months after initial treatment (probably due to incomplete resection of the primary index tumor or implantation after the biopsy). Residual tumors have little prospect of being affected by any chemoprevention. ? Prostatic, prostatic urethral, or upper tract transitional cell carcinoma involvement by the index tumor at resection ? Advanced disease or muscle invasion ? Metastatic disease ? Any other malignancy within the past 5 years ? Any other serious medical or psychiatric illness that would preclude giving informed consent ? Known hypersensitivity or adverse reactions to selenium ? Additional concurrent selenium (contained in individual supplements, antioxidant mix, or multivitamin) intake. ? Prior daily dietary supplements containing selenium within the last 30 days. ? Concurrent participation in another study involving a medical, surgical, nutritional, or life-style intervention (unless no longer receiving the intervention and are in the follow-up phase only) ? Any condition, which, in the opinion of the investigator might interfere with the safety of the patient or the evaluation of the study objectives
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to determine the effect of selenium, in addition to standard care, on the recurrence of bladder cancer. ;Secondary Objective: A secondary objective is to determine the effect of the treatment regimens on the recurrence and progression of bladder cancer in terms of histological type, number and size of the tumors in these participants. ;Primary end point(s): ? Recurrence-free interval in patients with superficial transitional cell carcinoma of the bladder This is defined as time from date of trial entry to date of recurrence. For those patients who are not observed to have a recurrence by time of analysis, the interval will be censored at the date last-known to be recurrence-free. A recurrence is defined as the new occurrence of a bladder cancer at the same or different site as the initial index primary cancer and excluding tumours identified at the first 3-month check cystoscopy. | — |
Countries
Belgium
Outcome results
None listed