Study of Genistein in Reducing Side Effects of Superficial Bladder Cancer Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01489813
Recruitment Status : Recruiting
First Posted : December 12, 2011
Last Update Posted : October 26, 2017
DSM Nutritional Products, Inc.
Information provided by (Responsible Party):
Omer Kucuk, Emory University

December 8, 2011
December 12, 2011
October 26, 2017
May 19, 2017
May 2020   (Final data collection date for primary outcome measure)
Change in severity of urinary symptoms as determined by the IPSS questionnaire score. [ Time Frame: At 6 weeks of treatment ]
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.
Same as current
Complete list of historical versions of study NCT01489813 on Archive Site
Rate of cancer recurrence determined at 10-week biopsy. [ Time Frame: At 10 weeks of treatment. ]
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.
Same as current
Not Provided
Not Provided
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
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.
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) 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 supplement (N=44) or placebo (N=44) during therapy and one month post therapy.
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Bladder Cancer
  • Drug: Genistein
    30 mg of genistein supplement by mouth three times daily (PO TID).
    Other Names:
    • Bonistein
    • I-Cool®
  • Drug: Sugar pill
    Sugar pills will be taken by mouth three times daily (PO TID).
    Other Name: Placebo pills
  • Placebo Comparator: Sugar pill
    Patients will be given placebo pills for 10 weeks.
    Intervention: Drug: Sugar pill
  • Experimental: Genistein supplement
    30 mg of genistein supplement by mouth three times daily (PO TID).
    Intervention: Drug: Genistein
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
May 2022
May 2020   (Final data collection date for primary outcome measure)

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

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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact: Omer Kucuk, MD 404-778-4538
Contact: Mersiha Torlak, MPH 404-778-4823
United States
EU2010-11 ( Other Identifier: Winship Cancer Institute of Emory University )
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Undecided
Omer Kucuk, Emory University
Emory University
DSM Nutritional Products, Inc.
Principal Investigator: Omer Kucuk, MD Emory University
Emory University
October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP