Study of Genistein in Reducing Side Effects of Superficial Bladder Cancer Treatment
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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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) 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 |
- Change in severity of urinary symptoms as determined by the IPSS questionnaire score. [ Time Frame: At 6 weeks of treatment ] [ Designated as safety issue: No ]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.
- Rate of cancer recurrence determined at 10-week biopsy. [ Time Frame: At 10 weeks of treatment. ] [ Designated as safety issue: No ]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 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2013 (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 BCG intravesical therapy for 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 |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male or female gender
- 18 years or older
- Diagnosis of superficial bladder cancer
- Scheduled for 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
Exclusion Criteria:
- Patients who are pregnant
- Diagnosis of invasive bladder cancer
- Unwillingness to follow study protocol and compliance procedures
- HIV positive or immunocompromised
- Presence of concurrent second cancer (active, not history)
Contacts and Locations| United States, Georgia | |
| Emory University Department of Urology | Not yet recruiting |
| Atlanta, Georgia, United States, 30322 | |
| Contact: Ruth Westby, BA 404-778-4162 rwestby@emory.edu | |
| Contact: Musu Sesay, MPH 404-778-6637 msesay@emory.edu | |
| Principal Investigator: Kenneth Ogan, MD | |
More Information
No publications provided
| Responsible Party: | Kenneth Ogan, MD, Associate Professor, Emory University |
| ClinicalTrials.gov Identifier: | NCT01489813 History of Changes |
| Other Study ID Numbers: | IRB00050273 |
| Study First Received: | December 8, 2011 |
| Last Updated: | June 5, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Urinary Bladder Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Neoplasms Urinary Bladder Diseases Urologic Diseases Contraceptives, Oral Genistein Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents Physiological Effects of Drugs |
Pharmacologic Actions Therapeutic Uses Phytoestrogens Estrogens, Non-Steroidal Estrogens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Anticarcinogenic Agents Protective Agents Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 22, 2013