Selenium and Vitamin E in Preventing Cancer Progression and Recurrence in Patients With Early-Stage Bladder Cancer
|ClinicalTrials.gov Identifier: NCT00553345|
Recruitment Status : Unknown
Verified February 2010 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : November 5, 2007
Last Update Posted : January 10, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Bladder Cancer||Drug: selenium Drug: vitamin E Procedure: chemoprevention||Phase 3|
- To investigate whether selenium and/or vitamin E (α-tocopherol) supplementation reduces the risk of recurrence and progression.
OUTLINE: This is a multicenter study. Patients are stratified by recurrence risk group (high vs intermediate) and treatment center and randomized to 1 of 4 treatment arms.
- Arm I: Patients receive oral selenium tablet and oral vitamin E capsule once daily.
- Arm II: Patients receive oral selenium tablet and oral placebo capsule once daily.
- Arm III: Patients receive oral placebo tablet and oral vitamin E capsule once daily.
- Arm IV: Patients receive oral placebo tablet and oral placebo capsule once daily.
In all arms, treatment continues for up to 5 years in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed every 6 months for 5 years.
Peer Reviewed and Funded or Endorsed by Cancer Research UK.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||515 participants|
|Official Title:||Bladder Cancer Prognosis Programme (Incorporating SELENIB Trial) [TREATMENT]|
|Study Start Date :||December 2005|
- Recurrence-free interval
- Overall survival time
- Incidence of transitional cell carcinoma outside the bladder
- Incidence of all other malignancies clinically diagnosed
- Incidence of cardiovascular events
- Quality of life as assessed at each follow-up visit by the quality of life instruments EORTC QLQ-C30, QLQ-BLS24 and QLQ-BLM30
- Progression-free interval
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00553345
|University of Birmingham||Recruiting|
|Birmingham, England, United Kingdom, B15 2TT|
|Contact: Maurice Zeegers 44 -121- 414- 6721|
|Study Chair:||Maurice Zeegers||University of Birmingham|