Bladder Cancer Clinical Trial
Official title:
Bladder Cancer Prognosis Programme (Incorporating SELENIB Trial) [TREATMENT]
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.
OBJECTIVES:
- 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.
;
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Prevention
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