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

This study is currently recruiting participants.
See Contacts and Locations
Verified May 2017 by Omer Kucuk, Emory University
Sponsor:
Information provided by (Responsible Party):
Omer Kucuk, Emory University
ClinicalTrials.gov Identifier:
NCT01489813
First received: December 8, 2011
Last updated: May 26, 2017
Last verified: May 2017
  Purpose
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 Intervention Phase
Bladder Cancer Drug: Genistein Drug: Sugar pill Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Omer Kucuk, Emory University:

Primary Outcome Measures:
  • Change in severity of urinary symptoms as determined by the IPSS questionnaire score. [ Time Frame: 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:
  • Rate of cancer recurrence determined at 10-week biopsy. [ Time Frame: 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.


Estimated Enrollment: 88
Actual Study Start Date: May 19, 2017
Estimated Study Completion Date: May 2022
Estimated Primary Completion Date: May 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Placebo pills
Experimental: Genistein
30 mg of Genistein by mouth three times daily (PO TID).
Drug: Genistein
30mg of Genistein supplements by mouth three times daily (PO TID).
Other Name: GeniVida

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 (N=44) or placebo (N=44) during therapy and one month post therapy.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female gender
  2. 18 years or older
  3. Diagnosis of superficial bladder cancer
  4. Scheduled for 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

Exclusion Criteria:

  1. Patients who are pregnant
  2. Diagnosis of invasive bladder cancer
  3. Unwillingness to follow study protocol and compliance procedures
  4. HIV positive or immunocompromised
  5. Presence of concurrent second cancer (active, not history)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01489813

Contacts
Contact: Omer Kucuk, MD 404-778-3448 omer.kucuk@emory.edu
Contact: Wilena Session 404-778-3448 wsessio@emory.edu

Locations
United States, Georgia
Emory University Department of Urology Recruiting
Atlanta, Georgia, United States, 30322
Contact: Mersiha Torlak, MPH    404-778-4823    mhotic@emory.edu   
Contact: Stephanie Spetka, BS    404-778-4162    sspetka@emory.edu   
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Omer Kucuk, MD Emory University
  More Information

Responsible Party: Omer Kucuk, Professor of Hematology-Oncology and Urology, Emory University
ClinicalTrials.gov Identifier: NCT01489813     History of Changes
Other Study ID Numbers: IRB00050273
EU2010-11 ( Other Identifier: Winship Cancer Institute of Emory University )
Study First Received: December 8, 2011
Last Updated: May 26, 2017
Individual Participant Data  
Plan to Share IPD: Undecided

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
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Genistein
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Phytoestrogens
Estrogens, Non-Steroidal
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on June 23, 2017