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Genistein for Bladder Cancer Side Effects

Phase 2

Waitlist Available

Led By Omer Kucuk, MD

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of superficial bladder cancer

18 years or older

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 6 weeks of treatment

Awards & highlights

Study Summary

This trial is testing whether a chemical found in soy beans can help with side effects from a treatment for bladder cancer.

Who is the study for?

This trial is for adults with non-invasive bladder cancer scheduled for BCG therapy. Participants must be willing to give blood samples, maintain a pill diary, and consent to the study. It's not open to pregnant individuals, those unwilling to follow the protocol, with concurrent second active cancer, muscle-invasive bladder cancer, or compromised immune systems.Check my eligibility

What is being tested?

The study tests if genistein (a soybean chemical) can reduce urinary tract symptoms from intravesical therapy in bladder cancer treatment compared to a placebo (sugar pill). Patients are randomly assigned to either take genistein or placebo over approximately four and a half months.See study design

What are the potential side effects?

While specific side effects of genistein aren't detailed here, it's generally being tested for its potential benefits on urinary symptoms related to bladder cancer treatments rather than adverse effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with early-stage bladder cancer.

Select...

I am 18 years old or older.

Select...

I am scheduled for BCG therapy for bladder cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 6 weeks of treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 6 weeks of treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 6 weeks of treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Rate of cancer recurrence determined at 10-week biopsy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Genistein supplementExperimental Treatment1 Intervention

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

Group II: Sugar pillPlacebo Group1 Intervention

Patients will be given placebo pills for 10 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Genistein

2005

Completed Phase 3

~510

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,687 Previous Clinical Trials

40,930,327 Total Patients Enrolled

National Institutes of Health (NIH)NIH

2,705 Previous Clinical Trials

7,507,242 Total Patients Enrolled

Emory UniversityLead Sponsor

1,642 Previous Clinical Trials

2,563,858 Total Patients Enrolled

Media Library

Genistein Clinical Trial Eligibility Overview. Trial Name: NCT01489813 — Phase 2

Bladder Cancer Research Study Groups: Genistein supplement, Sugar pill

Bladder Cancer Clinical Trial 2023: Genistein Highlights & Side Effects. Trial Name: NCT01489813 — Phase 2

Genistein 2023 Treatment Timeline for Medical Study. Trial Name: NCT01489813 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are selected to participate in this clinical research?

"At the moment, this clinical trial is not looking for more patients. However, it's worth noting that the study was originally posted on May 19th, 2017 and last edited December 10th, 2021. Additionally, if you are still seeking a study to participate in, there are presently 393 studies actively searching for patients with urinary bladder cancer and 2 studies for Genistein admitting patients."

Answered by AI

Are there precedent studies which suggest that Genistein is effective?

"As of now, there are two active clinical trials studying Genistein. Neither of these studies have progressed to Phase 3 yet. The majority of research on Genistein takes place in Atlanta, Georgia; however, there are 8 different locations running trials for this medication."

Answered by AI

Genistein is often consumed to alleviate what health issues?

"Genistein is often used to treat patients with osteomalacia. Additionally, this medication can be helpful for those struggling with vitamin d deficiency, calcium deficiency, and osteodystrophy."

Answered by AI

Are patients still being accepted into this research program?

"Unfortunately, this study is not presently looking for any more participants. The clinical trial was originally posted on May 19th, 2017 and updated most recently on December 10th, 2021. Although this current study is not enrolling patients, there are other active trials that might be of interest. In particular, 393 trials are actively recruiting patients with urinary bladder cancer while 2 studies involving Genistein are also still enrolling individuals."

Answered by AI

What is the stance of the FDA on Genistein?

"While there is some data supporting Genistein's safety, it lacks evidence of efficacy, so it received a score of 2."

Answered by AI

Has this research been done before?

"There are currently 2 ongoing studies for Genistein in 5 cities and 1 country. The first trial for Genistein was conducted in 2017 by DSM Nutritional Products, Inc.. That study completed its Phase 2 drug approval stage with 44 patients. Since 2017, 51 trials have been conducted in total."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Omer Kucuk 2017. "Study of Genistein in Reducing Side Effects of Superficial Bladder Cancer Treatment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01489813.

All > Paid Studies Georgia > Bladder Cancer