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

• Sponsor: Emory University (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT01489813
• Collaborator: DSM Nutritional Products, Inc. (Industry)
• Enrollment: 44
• Locations: 3
• Arms: 2
• Anticipated Duration (Months): 87.4
• Patients Per Site: 14.7
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bladder Cancer	Drug: Genistein; Drug: Sugar pill	Phase 2

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

• Study Type: Interventional
• Actual Enrollment: 44 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Phase II Randomized Placebo-Controlled Clinical Trial of Genistein in Reducing the Toxicity and Improving the Efficacy of Intravesical Therapy
• Actual Study Start Date: May 19, 2017
• Anticipated Primary Completion Date: Aug 31, 2022
• Anticipated Study Completion Date: Aug 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Sugar pill Patients will be given placebo pills for 10 weeks.	Drug: Sugar pill; Sugar pills will be taken by mouth three times daily (PO TID).; Other Names: Placebo pills
Experimental: Genistein supplement 30 mg of genistein supplement by mouth three times daily (PO TID) for 10 weeks.	Drug: Genistein; 30 mg of genistein supplement by mouth three times daily (PO TID).; Other Names: Bonistein I-Cool®

Outcome Measures

Primary Outcome Measures

1. Change in severity of urinary symptoms as determined by the IPSS questionnaire score. [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.

Secondary Outcome Measures

1. Rate of cancer recurrence determined at 10-week biopsy. [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Emory University Hospital Midtown	Atlanta	Georgia	United States	30308
2	Emory University Department of Urology	Atlanta	Georgia	United States	30322
3	Emory Saint Joseph's Hospital	Atlanta	Georgia	United States	30342

Sponsors and Collaborators

• Emory University
• DSM Nutritional Products, Inc.

Investigators

• Principal Investigator: Omer Kucuk, MD, Emory University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Omer Kucuk, Professor, Emory University
• ClinicalTrials.gov Identifier: NCT01489813
• Other Study ID Numbers: IRB00050273; EU2010-11
• First Posted: Dec 12, 2011
• Last Update Posted: Dec 13, 2021
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Urinary Bladder Neoplasms; Genistein

Study Results

No Results Posted as of Dec 13, 2021