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Trial Title:
Study of Genistein in Reducing Side Effects of Superficial Bladder Cancer Treatment
NCT ID:
NCT01489813
Condition:
Bladder Cancer
Conditions: Official terms:
Urinary Bladder Neoplasms
Genistein
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Participant)
Intervention:
Intervention type:
Drug
Intervention name:
Genistein
Description:
30 mg of genistein supplement by mouth three times daily (PO TID).
Arm group label:
Genistein supplement
Other name:
Bonistein
Other name:
I-Cool®
Intervention type:
Drug
Intervention name:
Sugar pill
Description:
Sugar pills will be taken by mouth three times daily (PO TID).
Arm group label:
Sugar pill
Other name:
Placebo pills
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.
Criteria for 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
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)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Emory University Hospital Midtown
Address:
City:
Atlanta
Zip:
30308
Country:
United States
Facility:
Name:
Emory University Department of Urology
Address:
City:
Atlanta
Zip:
30322
Country:
United States
Facility:
Name:
Emory Saint Joseph's Hospital
Address:
City:
Atlanta
Zip:
30342
Country:
United States
Start date:
May 19, 2017
Completion date:
August 31, 2024
Lead sponsor:
Agency:
Emory University
Agency class:
Other
Collaborator:
Agency:
DSM Nutritional Products, Inc.
Agency class:
Industry
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Collaborator:
Agency:
National Institutes of Health (NIH)
Agency class:
NIH
Source:
Emory University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01489813
