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


Phase 2
18 Years
N/A
Not Enrolling
Both
Bladder Cancer

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Trial Information

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


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.


Inclusion Criteria:



1. Male or female gender

2. 18 years or older

3. Diagnosis of superficial bladder cancer

4. Scheduled for 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 invasive bladder cancer

3. Unwillingness to follow study protocol and compliance procedures

4. HIV positive or immunocompromised

5. Presence of concurrent second cancer (active, not history)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Outcome Measure:

Change in severity of urinary symptoms as determined by the IPSS questionnaire score.

Outcome Description:

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.

Outcome Time Frame:

At 6 weeks of treatment

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

IRB00050273

NCT ID:

NCT01489813

Start Date:

July 2012

Completion Date:

December 2014

Related Keywords:

  • Bladder Cancer
  • Urinary Bladder Neoplasms

Name

Location

Emory University Department of Urology Atlanta, Georgia  30322