Study of Genistein in Reducing Side Effects of Superficial Bladder Cancer Treatment
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||Phase II Randomized Placebo-Controlled Clinical Trial of Genistein in Reducing the Toxicity and Improving the Efficacy of Intravesical Therapy|
- Change in severity of urinary symptoms as determined by the IPSS questionnaire score. [ Time Frame: At 6 weeks of treatment ] [ Designated as safety issue: No ]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.
- Rate of cancer recurrence determined at 10-week biopsy. [ Time Frame: At 10 weeks of treatment. ] [ Designated as safety issue: No ]A secondary study endpoint will be the presence of cancer and the rate of recurrence as determined by the 10-week biopsy or subsequent standard follow-up visits.
|Study Start Date:||December 2014|
|Estimated Study Completion Date:||December 2017|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
Placebo Comparator: Sugar pill
Patients will be given placebo pills for 10 weeks.
Drug: Sugar pill
Sugar pills will be taken by mouth three times daily (PO TID).
Other Name: Placebo pills
30 mg of Genistein by mouth three times daily (PO TID).
30mg of Genistein supplements by mouth three times daily (PO TID).
Other Name: GeniVida
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01489813
|United States, Georgia|
|Emory University Department of Urology||Not yet recruiting|
|Atlanta, Georgia, United States, 30322|
|Contact: Ruth Westby, BA 404-778-4162 firstname.lastname@example.org|
|Contact: Musu Sesay, MPH 404-778-6637 email@example.com|
|Principal Investigator: Kenneth Ogan, MD|