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

NCT01489813 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: IRB00050273EU2010-11P30CA138292
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 3

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.

Conditions

Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• 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

  At baseline and after 6 weeks of treatment

Secondary Outcomes (1)

• Number of Participants With Cancer Recurrence Determined at 10-week Biopsy.

  At 10 weeks of treatment.

Study Arms (2)

Sugar pill

PLACEBO COMPARATOR

Patients will be given placebo pills for 10 weeks.

Drug: Sugar pill

Genistein supplement

EXPERIMENTAL

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

Drug: Genistein

Interventions

Genistein DRUG

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

Also known as: Bonistein, I-Cool®

Genistein supplement

Sugar pill DRUG

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

Also known as: Placebo pills

Sugar pill

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female gender
• 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!

You may not qualify if:

• 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)

Sponsors & Collaborators

• Emory University: lead
• DSM Nutritional Products, Inc.: collaborator
• National Cancer Institute (NCI): collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (3)

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

Location

Emory University Department of Urology

Atlanta, Georgia, 30322, United States

Location

Emory Saint Joseph's Hospital

Atlanta, Georgia, 30342, United States

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Genistein; Sugars

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Isoflavones; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Carbohydrates

Limitations and Caveats

Actual enrollment was 36 subjects as reflected in the study data. Accrual did not meet the projected enrollment number due to lack of interest amongst patients and insufficient population within clinic.

Results Point of Contact

• Title: Omer Kucuk
• Organization: Emory University

okucuk@emory.edu

404-778-4729

Study Officials

• Omer Kucuk, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 8, 2011
• First Posted: December 12, 2011
• Study Start: May 19, 2017
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2024
• Last Updated: February 5, 2025
• Results First Posted: July 25, 2024

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)