Phase 2
N=36
Study of Genistein in Reducing Side Effects of Superficial Bladder Cancer Treatment
Bladder Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01489813 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcome: Primary: Change in Severity of Urinary Symptoms as Determined by the The International Prostate Symptom Score (IPSS) Questionnaire Score. — -2; -3 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Genistein (Drug); Sugar pill (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Emory University
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Severity of Urinary Symptoms as Determined by the The International Prostate Symptom Score (IPSS) Questionnaire Score. |
-2; -3 | — |
| SECONDARY Number of Participants With Cancer Recurrence Determined at 10-week Biopsy. |
7; 10 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Male or female gender
- 18 years or older
- Diagnosis of superficial bladder cancer
- Scheduled for induction BCG intravesical therapy
- Willing and able to give blood sample
- Willing and able to fill out a pill diary to ensure compliance
- Willing and able to sign informed consent
- Birth control is not required for this study!
Exclusion Criteria
- Patients who are pregnant
- Diagnosis of muscle-invasive bladder cancer
- Unwillingness to follow study protocol and compliance procedures
- HIV positive or immunocompromised
- Receiving concurrent immunotherapy or chemotherapy
- Presence of concurrent second cancer (active, not history)
Data sourced from ClinicalTrials.gov (NCT01489813). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.