Phase II Randomized Placebo-Controlled Clinical Trial of Genistein in Reducing the Toxicity and Improving the Efficacy of Intravesical Therapy
Patients who are treated with BCG intravesical therapy for TaT1 Tis superficial bladder
cancer often develop adverse effects (urinary tract symptoms) which limit the dose (and
therefore the efficacy) of therapy and result in poor quality of life. Genistein is a
nutritional supplement with anti-inflammatory properties which might help alleviate adverse
effects of intravesical therapy that are due to inflammation. Additionally, genistein also
has anti-tumor and immunopotentiating properties and has been shown to have no known side
effects. Our hypothesis is that genistein given together with BCG intravesical therapy will
reduce its adverse effects and improve the efficacy of therapy. Patients (N=88) scheduled
for intravesical therapy will be randomly assigned to take 30 mg tablets PO TID of genistein
(N=44) or placebo (N=44) during therapy and one month post therapy.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Change in severity of urinary symptoms as determined by the IPSS questionnaire score.
The change in severity of urinary symptoms as determined by the International Prostate Symptom Score (IPSS) questionnaire score. IPSS scores at 6 weeks of treatment will be compared to scores at baseline of treatment.
At 6 weeks of treatment
United States: Food and Drug Administration
|Emory University Department of Urology||Atlanta, Georgia 30322|