Bladder CancerPhase 2NCT01489813
Study of Genistein in Reducing Side Effects of Superficial Bladder Cancer Treatment
A Phase 2 study testing Genistein and Sugar pill in people with Bladder Cancer, run by Emory University at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Genistein and Sugar pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 3 sitesUnited States
- Study dates
- 19 May 2017to 31 Aug 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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!
Who cannot join
- 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)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Emory University Department of Urology
Atlanta, Georgia, 30322
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342
About this study
Official title: 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.
Read the 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.
- Conditions
- Bladder Cancer
- Being tested
- Genistein, Sugar pill
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GenisteinDrug
Also called Bonistein, I-Cool®
30 mg of genistein supplement by mouth three times daily (PO TID).
Sugar pillDrug
Also called Placebo pills
Sugar pills will be taken by mouth three times daily (PO TID).
| Study group | Role | What they receive |
|---|---|---|
| Sugar pill | Placebo comparator | Patients will be given placebo pills for 10 weeks. Receives: Drug: Sugar pill |
| Genistein supplement | Experimental | 30 mg of genistein supplement by mouth three times daily (PO TID) for 10 weeks. Receives: Drug: Genistein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Severity of Urinary Symptoms as Determined by the The International Prostate Symptom Score (IPSS) Questionnaire Score.
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. Lower values indicate a better outcome.
0 to 7 points: Mild symptoms 8 to 19 points: Moderate symptoms 20 to 35 points: Severe symptoms
Measured: At baseline and after 6 weeks of treatment
Secondary outcomes (1)
Number of Participants With Cancer Recurrence Determined at 10-week Biopsy.
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.
Measured: At 10 weeks of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2011 (estimated)
- Study start19 May 2017
- Primary completion31 Aug 2023
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- dsm-firmenich Switzerland AG, National Cancer Institute (NCI), National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Omer Kucuk, Emory University
- Investigators
- Omer Kucuk, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01489813
- Sponsor's protocol ID
- IRB00050273
- Other IDs
- EU2010-11, P30CA138292
- Status last verified
- Jan 2025
- First submitted
- 8 Dec 2011
- Last updated
- 5 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Randomized Placebo-Controlled Clinical Trial of Genistein in Reducing the Toxicity and Improving the Efficacy of Intravesical Therapy
- ClinicalTrials.gov ID
- NCT01489813
- Acronym / sponsor ID
- IRB00050273
- Conditions
- Bladder Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- dsm-firmenich Switzerland AG, National Cancer Institute (NCI), National Institutes of Health (NIH)
- Study start
- 19 May 2017 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 12 Dec 2011 (estimated)
- Results
- Posted 25 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sugar pill | Placebo comparator | Drug: Sugar pillPatients will be given placebo pills for 10 weeks. |
| Genistein supplement | Experimental | Drug: Genistein30 mg of genistein supplement by mouth three times daily (PO TID) for 10 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GenisteinAlso: Bonistein, I-Cool®30 mg of genistein supplement by mouth three times daily (PO TID). | Drug | Genistein supplement |
| Sugar pillAlso: Placebo pillsSugar pills will be taken by mouth three times daily (PO TID). | Drug | Sugar pill |
Primary outcome
Change in Severity of Urinary Symptoms as Determined by the The International Prostate Symptom Score (IPSS) Questionnaire Score.
Time frame: At baseline and after 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. Lower values indicate a better outcome. 0 to 7 points: Mild symptoms 8 to 19 points: Moderate symptoms 20 to 35 points: Severe symptoms
1 secondary outcome
Number of Participants With Cancer Recurrence Determined at 10-week Biopsy.
Time frame: At 10 weeks of treatment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Omer Kucuk, MD principal investigator
Emory University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Genistein and Sugar pill in people with Bladder Cancer, run by Emory University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Severity of Urinary Symptoms as Determined by the The International Prostate Symptom Score (IPSS) Questionnaire Score. (time frame: At baseline and after 6 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2025.