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BRIEF TITLE: Randomized Placebo-Controlled Clinical Trial of Genistein in Reducing the Toxicity and Improving the Efficacy of Intravesical Therapy

Phase II Randomized Placebo-Controlled Clinical Trial of Genistein in Reducing the Toxicity and Improving the Efficacy of Intravesical Therapy


  • Org Study ID: IRB00050273
  • Secondary ID: EU2010-11
  • NCT ID: NCT01489813
  • NCT Alias:
  • Sponsor: Emory University - Other
  • Source: 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.

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.

Overal Status Start Date Phase Study Type
Recruiting May 19, 2017 Phase 2 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Change in severity of urinary symptoms as determined by the IPSS questionnaire score.

Primary Outcome 1 - Time Frame: At 6 weeks of treatment

Condition:

  • Bladder Cancer

Eligibility

Criteria:
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)
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Omer Kucuk, MD

Role: Principal Investigator

Affiliation: Emory University

Overall Contact

Name: Omer Kucuk, MD

Phone: 404-778-4538

Email: omer.kucuk@emory.edu

Locations

Facility Status Contact
Emory University Department of Urology
Atlanta, Georgia 30322
United States
Recruiting Ella Anastasiades, BA
404-778-4538
ella.anastasiades@emory.edu
Emory Saint Joseph's Hospital
Atlanta, Georgia 30342
United States
Recruiting Ella Anastasiades, BA
404-778-4538
ella.anastasiades@emory.edu