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

NCT ID: NCT01489813

Last Updated: 2025-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-19
• Study Completion Date: 2024-08-31

Brief 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.

Conditions

Bladder Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Sugar pill

Patients will be given placebo pills for 10 weeks.

Group Type: PLACEBO_COMPARATOR

Sugar pill

Intervention Type: DRUG

Sugar pills will be taken by mouth three times daily (PO TID).

Genistein supplement

30 mg of genistein supplement by mouth three times daily (PO TID) for 10 weeks.

Group Type: EXPERIMENTAL

Genistein

Intervention Type: DRUG

30 mg of genistein supplement by mouth three times daily (PO TID).

Interventions

Genistein

30 mg of genistein supplement by mouth three times daily (PO TID).

Intervention Type: DRUG

Sugar pill

Sugar pills will be taken by mouth three times daily (PO TID).

Intervention Type: DRUG

Other Intervention Names

Bonistein; I-Cool®; Placebo pills

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DSM Nutritional Products, Inc.

INDUSTRY

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Omer Kucuk

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Omer Kucuk, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory University Hospital Midtown

Atlanta, Georgia, United States

Emory University Department of Urology

Atlanta, Georgia, United States

Emory Saint Joseph's Hospital

Atlanta, Georgia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

EU2010-11

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA138292

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00050273

Identifier Type: -

Identifier Source: org_study_id