What side effects are associated with this type of intervention?

Intravesical therapy, commonly used for non-invasive bladder cancer, can cause several lower urinary tract symptoms such as frequent urination, urgency, pain during urination, and bladder spasms. These side effects can limit the dose and efficacy of the treatment. Other treatments for bladder cancer, such as radical cystectomy, can lead to significant surgical risks including infection, bleeding, and complications related to urinary diversion. Systemic therapies like chemotherapy and immunotherapy may cause broader side effects including fatigue, nausea, and increased susceptibility to infections.

What prior FDA approvals exist?

FDA-approved treatments for bladder cancer include intravesical therapies like Bacillus Calmette-Guérin (BCG) and mitomycin, which are used to prevent recurrence in non-muscle invasive bladder cancer. Systemic treatments for advanced bladder cancer include chemotherapy agents such as gemcitabine and cisplatin, as well as immunotherapies like pembrolizumab and atezolizumab. These treatments aim to manage symptoms and improve survival rates, similar to the goals of the Genistein trial, which seeks to reduce lower urinary tract symptoms and impact recurrence rates.

What other types of research exist?

Promising novel alternatives to Genistein for bladder cancer patients include Mitomycin C and Epigallocatechin Gallate (EGCG). Mitomycin C is often used intravesically postoperatively to prevent tumor cell implantation and regrowth. EGCG, a polyphenolic catechin found in green tea, has shown efficacy in preventing tumor cell implantation and growth in experimental models. Both alternatives have demonstrated potential in reducing recurrence rates and may offer benefits in managing lower urinary tract symptoms.

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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

Must not have

Diagnosis of muscle-invasive bladder cancer

Unwillingness to follow study protocol and compliance procedures

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 10 weeks of treatment.

Summary

This trial is testing whether a soy-based pill called genistein can help reduce side effects and improve the effectiveness of bladder cancer treatment. It targets patients with non-muscle invasive bladder cancer who are undergoing BCG therapy. Genistein may reduce inflammation and boost the immune system, making the treatment more comfortable and effective. Genistein, a soy compound, has been observed to inhibit bladder cancer growth.

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.

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.

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

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I have been diagnosed with early-stage bladder cancer.

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I am 18 years old or older.

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I am scheduled for BCG therapy for bladder cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with bladder cancer that has grown into the bladder muscle.

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I am willing to follow the study's rules and procedures.

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I am currently receiving immunotherapy or chemotherapy.

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I currently have more than one type of cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 10 weeks of treatment.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 10 weeks of treatment.

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 10 weeks of treatment. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Severity of Urinary Symptoms as Determined by the The International Prostate Symptom Score (IPSS) Questionnaire Score.

Secondary study objectives

Number of Participants With 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 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for bladder cancer include intravesical therapy, chemotherapy, and emerging agents like genistein. Intravesical therapy involves directly administering therapeutic agents into the bladder to target cancer cells locally, reducing systemic side effects. Chemotherapy, often using agents like cisplatin, works by damaging the DNA of rapidly dividing cancer cells, leading to cell death. Genistein, a soy-derived compound, is being studied for its potential to reduce lower urinary tract symptoms and impact recurrence rates by modulating cellular pathways involved in cancer progression. These treatments are crucial for bladder cancer patients as they aim to effectively manage the disease while minimizing adverse effects and improving quality of life.

Effects of Epigallocatechin Gallate (EGCG) on Urinary Bladder Urothelial Carcinoma-Next-Generation Sequencing and Bioinformatics Approaches.p53 and retinoblastoma pathways in bladder cancer.

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,957 Previous Clinical Trials

41,112,051 Total Patients Enrolled

National Institutes of Health (NIH)NIH

2,840 Previous Clinical Trials

8,172,584 Total Patients Enrolled

Emory UniversityLead Sponsor

1,708 Previous Clinical Trials

2,607,448 Total Patients Enrolled

DSM Nutritional Products, Inc.Industry Sponsor

96 Previous Clinical Trials

57,198 Total Patients Enrolled

Omer Kucuk, MD4.49 ReviewsPrincipal Investigator - Emory University

Emory University

7 Previous Clinical Trials

2,029 Total Patients Enrolled

5Patient Review

I was a patient of Dr. Kucuk in 2005 and found him to be very comprehensive in his treatments and explanations. He always had time for questions, and when I was feeling down, he was always able to lift my spirits.