Bladder Cancer Clinical Trial
Official title:
Megadose Vitamins as Chemoprevention of Transitional Cell Carcinoma of the Bladder
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the
development or recurrence of cancer. The use of high-dose multivitamins may be an effective
way to prevent the recurrence of early stage bladder cancer. It is not yet known whether
high-dose vitamins are more effective than no further therapy in decreasing the risk of
early-stage bladder cancer.
PURPOSE: Randomized double-blinded phase III trial to compare the effectiveness of high-dose
multivitamins with a placebo in preventing the recurrence of cancer in patients with early
stage bladder cancer.
OBJECTIVE: I. Determine whether high dose multivitamins have chemopreventive efficacy beyond
standard therapy in reducing the risk of recurrence in patients with resected stage 0 and I
(Ta, T1, and Tis) transitional cell carcinoma of the bladder.
OUTLINE: This is a randomized, double blind study. Patients are randomized to receive
multivitamins or placebo orally once daily for 3 years. Patients are followed every 3 months
for 2 years, then every 6 months for 1 year, and then annually thereafter.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
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