Study of Genistein in Reducing Side Effects of Superficial Bladder Cancer Treatment

Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01489813
• Other study ID #: IRB00050273
• Secondary ID: EU2010-11P30CA13
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: May 19, 2017
• Est. completion date: August 31, 2024

Study information

• Verified date: May 2023
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 44
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Drug:
• Genistein
30 mg of genistein supplement by mouth three times daily (PO TID).
• Sugar pill
Sugar pills will be taken by mouth three times daily (PO TID).

Locations

Country	Name	City	State
United States	Emory Saint Joseph's Hospital	Atlanta	Georgia
United States	Emory University Department of Urology	Atlanta	Georgia
United States	Emory University Hospital Midtown	Atlanta	Georgia

Sponsors (4)

Lead Sponsor	Collaborator
Emory University	DSM Nutritional Products, Inc., National Cancer Institute (NCI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in severity of urinary symptoms as determined by the 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.	At 6 weeks of treatment
Secondary	Rate of 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.	At 10 weeks of treatment.