Selenium in Preventing Cancer Recurrence in Patients With Bladder Cancer

Bladder Cancer Clinical Trial

Official title:

Phase III Randomized Chemoprevention Study of Selenium on the Recurrence of Non-invasive Bladder Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00729287
• Other study ID #: CDR0000602239
• Secondary ID: UZG-CUL-UHG-Non-
• Status: Recruiting
• Phase: Phase 3
• First received: August 6, 2008
• Last updated: November 10, 2009
• Start date: June 2008

Study information

• Verified date: June 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 900
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Dietary Supplement:
• selenium
Given orally

Other:
• placebo
Given orally

Locations

Country	Name	City	State
Belgium	U.Z. Gasthuisberg	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Gasthuisberg

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of selenium in preventing the recurrence of bladder cancer			No
Secondary	Effect of selenium on the recurrence of bladder cancer, in terms of histological type, number, and size			No