Clinical trial · Interventional
Study of Genistein in Reducing Side Effects of Superficial Bladder Cancer Treatment
Phase II Randomized Placebo-Controlled Clinical Trial of Genistein in Reducing the Toxicity and Improving the Efficacy of Intravesical Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Genistein | Drug | — | UNRESOLVED |
| Sugar pill | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Sugar pill
- description
- Patients will be given placebo pills for 10 weeks.
- interventionNames
- Drug: Sugar pill
- type
- EXPERIMENTAL
- label
- Genistein supplement
- description
- 30 mg of genistein supplement by mouth three times daily (PO TID) for 10 weeks.
- interventionNames
- Drug: Genistein
Primary outcomes (1)
- measure
- Change in Severity of Urinary Symptoms as Determined by the The International Prostate Symptom Score (IPSS) Questionnaire Score.
- timeFrame
- At baseline and after 6 weeks of treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Male or female gender 2. 18 years or older 3. Diagnosis of superficial bladder cancer 4. Scheduled for induction BCG intravesical therapy 5. Willing and able to give blood sample 6. Willing and able to fill out a pill diary to ensure compliance 7. Willing and able to sign informed consent 8. Birth control is not required for this study! Exclusion Criteria: 1. Patients who are pregnant 2. Diagnosis of muscle-invasive bladder cancer 3. Unwillingness to follow study protocol and compliance procedures 4. HIV positive or immunocompromised 5. Receiving concurrent immunotherapy or chemotherapy 6. Presence of concurrent second cancer (active, not history)
References
Publications (0)
Data not yet available