- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01489813
Study of Genistein in Reducing Side Effects of Superficial Bladder Cancer Treatment
May 3, 2023 updated by: Omer Kucuk, Emory University
Phase II Randomized Placebo-Controlled Clinical Trial of Genistein in Reducing the Toxicity and Improving the Efficacy of Intravesical Therapy
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 Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
44
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Georgia
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Atlanta, Georgia, United States, 30308
- Emory University Hospital Midtown
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Atlanta, Georgia, United States, 30342
- Emory Saint Joseph's Hospital
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Atlanta, Georgia, United States, 30322
- Emory University Department of Urology
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Male or female gender
- 18 years or older
- Diagnosis of superficial bladder cancer
- Scheduled for induction BCG intravesical therapy
- Willing and able to give blood sample
- Willing and able to fill out a pill diary to ensure compliance
- Willing and able to sign informed consent
- Birth control is not required for this study!
Exclusion Criteria:
- Patients who are pregnant
- Diagnosis of muscle-invasive bladder cancer
- Unwillingness to follow study protocol and compliance procedures
- HIV positive or immunocompromised
- Receiving concurrent immunotherapy or chemotherapy
- Presence of concurrent second cancer (active, not history)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Sugar pill
Patients will be given placebo pills for 10 weeks.
|
Sugar pills will be taken by mouth three times daily (PO TID).
Other Names:
|
Experimental: Genistein supplement
30 mg of genistein supplement by mouth three times daily (PO TID) for 10 weeks.
|
30 mg of genistein supplement by mouth three times daily (PO TID).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in severity of urinary symptoms as determined by the IPSS questionnaire score.
Time Frame: At 6 weeks of treatment
|
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.
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At 6 weeks of treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of cancer recurrence determined at 10-week biopsy.
Time Frame: At 10 weeks of treatment.
|
A secondary study endpoint will be the presence of cancer and the rate of recurrence as determined by the 10-week biopsy or subsequent standard follow-up visits.
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At 10 weeks of treatment.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Omer Kucuk, MD, Emory University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 19, 2017
Primary Completion (Anticipated)
August 31, 2023
Study Completion (Anticipated)
August 31, 2024
Study Registration Dates
First Submitted
December 8, 2011
First Submitted That Met QC Criteria
December 9, 2011
First Posted (Estimate)
December 12, 2011
Study Record Updates
Last Update Posted (Estimate)
May 5, 2023
Last Update Submitted That Met QC Criteria
May 3, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Urologic Diseases
- Urinary Bladder Diseases
- Urinary Bladder Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Protective Agents
- Estrogens, Non-Steroidal
- Estrogens
- Protein Kinase Inhibitors
- Anticarcinogenic Agents
- Phytoestrogens
- Genistein
Other Study ID Numbers
- IRB00050273
- P30CA138292 (U.S. NIH Grant/Contract)
- EU2010-11 (Other Identifier: Winship Cancer Institute of Emory University)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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