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

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

Condition: Bladder Cancer

Intervention:

  • Drug: Genistein
  • Drug: Sugar pill

Purpose: 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 Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT01489813

Sponsor: Emory University

Primary Outcome Measures:

  • Measure: Change in severity of urinary symptoms as determined by the IPSS questionnaire score.
  • Time Frame: At 6 weeks of treatment
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Rate of cancer recurrence determined at 10-week biopsy.
  • Time Frame: At 10 weeks of treatment.
  • Safety Issue:

Estimated Enrollment: 44

Study Start Date: May 19, 2017

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

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)

Contact:

  • Omer Kucuk, MD
  • 404-778-4538

Locations:

  • Emory University Department of Urology
  • Atlanta Georgia 30322 United States
  • Emory Saint Joseph’s Hospital
  • Atlanta Georgia 30342 United States

View trial on ClinicalTrials.gov

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