Selenium in Preventing Cancer Recurrence in Patients With Bladder Cancer
Conditions
Bladder Cancer
Conditions: official terms
Urinary Bladder Neoplasms
Conditions: Keywords
stage 0 bladder cancer, stage I bladder cancer, transitional cell carcinoma of the bladder
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
Intervention
Name: selenium Type: Dietary Supplement
Name: placebo Type: Other
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: DISEASE CHARACTERISTICS:

- Histopathologically confirmed non-muscle-invasive transitional cell carcinoma (TCC) of the bladder (< pT2 ), meeting any of the following criteria:

- Solitary grade 1, pTa (≥ 3 cm) tumor

- Any other pTa, pTis (carcinoma in situ), or pT1 tumor

- Newly diagnosed disease

- Meets 1 of the following risk criteria for recurrence:

- Intermediate-risk disease

- Multiple grade 1, pTa (> 1) tumor

- Solitary grade 1, pTa (≥ 3 cm) tumor

- Grade 2, pTa tumor

- Grade 1, pT1 tumor

- Grade 2, pT1 (1 or 2 tumors)

- High-risk disease

- Grade 3, pTa tumor

- Grade 3, pT1 tumor

- Tis (carcinoma in situ)

- Multiple grade 2, pT1 (≥ 3 foci) tumor

- Has undergone diagnostic transurethral resection of the bladder tumor/biopsy within the past 3 months

- No residual tumor, defined as a recurrence within 3 months after initial treatment (due to incomplete resection of the primary index tumor or implantation after biopsy)

- No prostatic, prostatic urethral, or upper tract TCC involvement by the index tumor at resection

- No muscle invasion or advanced disease

- No metastatic disease

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
Location
U.Z. Gasthuisberg
Leuven, Belgium
Status: Recruiting
Contact: Frank Buntinx, MD - 32-16-337-493
Start Date
June 2008
Sponsors
U.Z. Gasthuisberg
Source
National Cancer Institute (NCI)
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page