Transitional Cell Carcinoma of the Bladder Clinical Trial
Official title:
Pilot Pre-cystectomy Trial of Broccoli Extract in Patients With Superficial or Locally Advanced Bladder Cancer
Rationale: Broccoli sprout extract contains ingredients that may prevent or slow the growth
of certain cancers.
Purpose: This pilot study is studying the side effects of broccoli sprout extract in
treating patients with transitional cell bladder cancer undergoing surgery.
Primary Objectives:
I. To determine the tolerability and toxicity of a broccoli sprout extract (providing 200
micro mol isothiocyanate/dose/per day) given for 14 days in patients destined to undergo
definitive bladder resection for bladder cancer.
Secondary Objectives:
I. Establish the safety of administration of the broccoli extract on the bladder surgery
specifically.
II. Determine the levels of isothiocyanates and their metabolites in urine, blood, benign
urothelium and bladder cancer tissue.
III. Assess the antitumor effects of broccoli extract on the primary bladder tumor by
measuring angiogenesis, cell proliferation and apoptosis.
IV. Determine the feasibility of treating patients with 200 micro mol isothiocyanate per
dose per day of broccoli sprout extract in future therapeutic and prevention clinical
trials.
Outline: Patients receive oral broccoli sprout extract once daily on days 1-14 in the
absence of disease progression or unacceptable toxicity. After completion of study
treatment, patients are followed at 4 weeks.
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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