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NCT01489813CompletedPhase 2

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

Phase II Randomized Placebo-Controlled Clinical Trial of Genistein in Reducing the Toxicity and Improving the Efficacy of Intravesical Therapy

Source: ClinicalTrials.gov · Last updated 5 Feb 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
36 (actual)
First submitted
8 Dec 2011
Start date
19 May 2017
Primary completion date
31 Aug 2023
Lead sponsor
Emory University
NCT number
NCT01489813

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 36
  • From 19 May 2017 to the primary completion date, 31 Aug 2023
  • 3 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Receiving concurrent immunotherapy or chemotherapy
  • Presence of concurrent second cancer (active, not history)

Other illness

  • Diagnosis of muscle-invasive bladder cancer
  • HIV positive or immunocompromised

Other

  • Patients who are pregnant
  • Unwillingness to follow study protocol and compliance procedures

Who the study is looking for

  • Male or female gender
  • 18 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!

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Emory University Hospital Midtown
Coordinator of this site? Confirm its status
AtlantaUnited StatesUnknown status
Emory Saint Joseph's Hospital
Coordinator of this site? Confirm its status
AtlantaUnited StatesUnknown status
Emory University Department of Urology
Coordinator of this site? Confirm its status
AtlantaUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.