CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 36 enrolled
Drug / intervention
Genistein +1 moredrug
Likely dose
Genistein 30 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01489813
NCT01489813Phase 2Completed

Phase II Randomized Placebo-Controlled Clinical Trial of Genistein in Reducing the Toxicity and Improving the Efficacy of Intravesical Therapy

Emory University·interventional·Posted Dec 12, 2011·Updated Feb 5, 2025

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

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBladder Cancer
CountriesUnited States

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedDec 12, 2011
Enrollment StartMay 19, 2017
Primary CompletionAug 31, 2023
Study CompletionAug 31, 2024
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 14.6 years ago

Interventions

Genisteindrug

30 mg of genistein supplement by mouth three times daily (PO TID).

Sugar pilldrug

Sugar pills will be taken by mouth three times daily (PO TID).