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Study of Genistein in Reducing Side Effects of Superficial Bladder Cancer Treatment
Conditions
Bladder Cancer
Conditions: official terms
Urinary Bladder Neoplasms
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Intervention
Name: Genistein
Type: Drug
Name: Sugar pill
Type: Drug
Overall Status
Not yet recruiting
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 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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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)
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)
Location
Emory University Department of Urology
Atlanta, Georgia, United States
Status: Not yet recruiting
Contact: Ruth Westby, BA - 404-778-4162 - rwestby@emory.edu
Start Date
June 2015
Completion Date
December 2018
Sponsors
Emory University
Source
Emory University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page