Status:
COMPLETED
Study of Genistein in Reducing Side Effects of Superficial Bladder Cancer Treatment
Lead Sponsor:
Emory University
Collaborating Sponsors:
DSM Nutritional Products, Inc.
National Cancer Institute (NCI)
Conditions:
Bladder Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 symp...
Detailed Description
Patients who are treated with bacillus Calmette-Guerin (BCG) intravesical therapy for non-muscle invasive (TaT1) Tis superficial bladder cancer often develop adverse effects (urinary tract symptoms) w...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
May 19 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2024
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01489813
Start Date
May 19 2017
End Date
August 31 2024
Last Update
February 5 2025
Active Locations (3)
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1
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
2
Emory University Department of Urology
Atlanta, Georgia, United States, 30322
3
Emory Saint Joseph's Hospital
Atlanta, Georgia, United States, 30342