This phase II trial studies how well genistein works in reducing the toxicity and improving the efficacy of Bacillus Calmette Guerin intravesical (within the bladder) therapy in patients with bladder cancer. Genistein may reduce adverse urinary tract symptoms due to inflammation from intravesical therapy and improve the quality of life of patients with bladder cancer. Genistein may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT01489813.
PRIMARY OBJECTIVE:
I. The change in severity of urinary symptoms over time as determined by the International Prostate Symptom Score (IPSS) questionnaire score, specifically comparing the symptoms at the 1st Bacillus Calmette Guerin (BCG) treatment (baseline) to the symptoms at the 6th week of treatment.
SECONDARY OBJECTIVES:
I. The presence of cancer and the rate of recurrence as determined by the 10-week biopsy or subsequent standard follow-up visits.
II. The total dose of intravesical therapy administered over the 6 weeks of treatment.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive placebo orally (PO) three times daily (TID) for 10 weeks.
ARM II: Patients receive genistein PO TID for 10 weeks.
After completion of study treatment, patients are followed up for 1 month.
Lead OrganizationEmory University Hospital/Winship Cancer Institute
Principal InvestigatorOmer Kucuk
