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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00729287

Acronym

SELEBLAT

Enrollment

276

Registered

2008-08-07

Start date

2009-09-30

Completion date

2015-12-31

Last updated

2016-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Cancer

Keywords

stage 0 bladder cancer, stage I bladder cancer, transitional cell carcinoma of the bladder

Brief summary

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.

Detailed description

OBJECTIVES: Primary * To determine the effect of selenium, when administered with standard care, in preventing the recurrence of bladder cancer in patients with non-muscle-invasive transitional cell carcinoma of the bladder at risk for recurrence. Secondary * To determine the effect of selenium on the recurrence of bladder cancer, in terms of histological type, number, and size. OUTLINE: Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive oral placebo daily in addition to standard care. * Arm II: Patients receive oral selenium daily in addition to standard care.

Interventions

DIETARY_SUPPLEMENTselenium

Given orally

OTHERplacebo

Given orally

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Effect of selenium in preventing the recurrence of bladder cancer	3 years

Secondary

Measure	Time frame
Effect of selenium on the progression of bladder cancer, in terms of histological type, number, and size	3 years

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026