At a glance
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Phase II Randomized Placebo-Controlled Clinical Trial of Genistein in Reducing the Toxicity and Improving the Efficacy of Intravesical Therapy
In Brief
A Phase 2 clinical trial evaluating Genistein and Sugar pill for Bladder Cancer. Completed, enrolled 36 participants across 3 sites.
Detailed Summary
Patients with non-invasive bladder cancer are often treated with intravesical therapy in order to prevent the recurrence of bladder cancer. Intravesical therapy can cause many lower urinary tract symptoms, which can limit the dose of therapy and therefore efficacy of treatment. There have been a number of studies that suggest a chemical found in soy beans may be able to help with these side effects. This chemical is called genistein and can be extracted and given to study subjects in pill form. In this study, the investigators would like to have patients placed into two different groups. One group would take genistein and the other group would take a placebo, a sugar pill that looks like the genistein pill. In doing this study the investigators hope to explore the findings from other studies to see if lower urinary tract symptoms are reduced and to see if recurrence rates for patients are affected by genistein. The study would take about four and a half months total.
Study Details
Timeline
Interventions
30 mg of genistein supplement by mouth three times daily (PO TID).
Sugar pills will be taken by mouth three times daily (PO TID).