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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 : November 20, 2020
DSM Nutritional Products, Inc.
Information provided by (Responsible Party):
Omer Kucuk, Emory University

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 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.

Condition or disease Intervention/treatment Phase
Bladder Cancer Drug: Genistein Drug: Sugar pill Phase 2

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) 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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
Actual Study Start Date : May 19, 2017
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : May 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer
Drug Information available for: Genistein

Arm Intervention/treatment
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

Experimental: Genistein supplement
30 mg of genistein supplement by mouth three times daily (PO TID) for 10 weeks.
Drug: Genistein
30 mg of genistein supplement by mouth three times daily (PO TID).
Other Names:
  • Bonistein
  • I-Cool®

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  8. Birth control is not required for this study!

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01489813

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Contact: Omer Kucuk, MD 404-778-0897
Contact: Mersiha Torlak, MPH 404-778-4823

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United States, Georgia
Emory University Hospital Midtown Recruiting
Atlanta, Georgia, United States, 30308
Contact: Katya Bobrek, BS    404-778-0897   
Contact: Mersiha Torlak, MPH    404-778-4823   
Emory University Department of Urology Recruiting
Atlanta, Georgia, United States, 30322
Contact: Katya Bobrek, BS    404-778-0897   
Contact: Mersiha Torlak, MPH    404-778-4823   
Emory Saint Joseph's Hospital Recruiting
Atlanta, Georgia, United States, 30342
Contact: Katya Bobrek, BS    404-778-0897   
Contact: Mersiha Torlak, MPH    404-778-4823   
Sponsors and Collaborators
Emory University
DSM Nutritional Products, Inc.
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Principal Investigator: Omer Kucuk, MD Emory University
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Responsible Party: Omer Kucuk, Professor, Emory University Identifier: NCT01489813    
Other Study ID Numbers: IRB00050273
EU2010-11 ( Other Identifier: Winship Cancer Institute of Emory University )
First Posted: December 12, 2011    Key Record Dates
Last Update Posted: November 20, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogens, Non-Steroidal
Hormones, Hormone Substitutes, and Hormone Antagonists