Bladder Cancer
Conditions
Brief summary
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.
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 supplement (N=44) or placebo (N=44) during therapy and one month post therapy.
Interventions
DRUGGenistein
30 mg of genistein supplement by mouth three times daily (PO TID).
DRUGSugar pill
Sugar pills will be taken by mouth three times daily (PO TID).
Sponsors
DSM Nutritional Products, Inc.
National Cancer Institute (NCI)
National Institutes of Health (NIH)
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female gender 2. 18 years or older 3. Diagnosis of superficial bladder cancer 4. Scheduled for induction 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 8. Birth control is not required for this study!
Exclusion criteria
1. Patients who are pregnant 2. Diagnosis of muscle-invasive bladder cancer 3. Unwillingness to follow study protocol and compliance procedures 4. HIV positive or immunocompromised 5. Receiving concurrent immunotherapy or chemotherapy 6. Presence of concurrent second cancer (active, not history)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Severity of Urinary Symptoms as Determined by the The International Prostate Symptom Score (IPSS) Questionnaire Score. | At baseline and after 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. Lower values indicate a better outcome. 0 to 7 points: Mild symptoms 8 to 19 points: Moderate symptoms 20 to 35 points: Severe symptoms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Cancer Recurrence Determined at 10-week Biopsy. | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sugar Pill Patients will be given placebo pills for 10 weeks.
Sugar pill: Sugar pills will be taken by mouth three times daily (PO TID). | 16 |
| Genistein Supplement 30 mg of genistein supplement by mouth three times daily (PO TID) for 10 weeks.
Genistein: 30 mg of genistein supplement by mouth three times daily (PO TID). | 20 |
| Total | 36 |
Baseline characteristics
| Characteristic | Sugar Pill | Genistein Supplement | Total |
|---|---|---|---|
| Age, Continuous | 73.2 years STANDARD_DEVIATION 8.3 | 71.2 years STANDARD_DEVIATION 8.7 | 71.5 years STANDARD_DEVIATION 8.4 |
| Number of Participants with Insurance | 13 Participants | 15 Participants | 28 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 7 Participants | 10 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) White | 12 Participants | 11 Participants | 23 Participants |
| Region of Enrollment United States | 16 participants | 20 participants | 36 participants |
| Sex: Female, Male Female | 1 Participants | 3 Participants | 4 Participants |
| Sex: Female, Male Male | 15 Participants | 17 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 20 |
| other Total, other adverse events | 3 / 16 | 3 / 20 |
| serious Total, serious adverse events | 0 / 16 | 0 / 20 |
Outcome results
Primary
Change in Severity of Urinary Symptoms as Determined by the The International Prostate Symptom Score (IPSS) Questionnaire Score.
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. Lower values indicate a better outcome. 0 to 7 points: Mild symptoms 8 to 19 points: Moderate symptoms 20 to 35 points: Severe symptoms
Time frame: At baseline and after 6 weeks of treatment
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sugar Pill | Change in Severity of Urinary Symptoms as Determined by the The International Prostate Symptom Score (IPSS) Questionnaire Score. | -2 score on a scale |
| Genistein Supplement | Change in Severity of Urinary Symptoms as Determined by the The International Prostate Symptom Score (IPSS) Questionnaire Score. | -3 score on a scale |
Secondary
Number of Participants With Cancer Recurrence Determined at 10-week Biopsy.
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.
Time frame: At 10 weeks of treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sugar Pill | Number of Participants With Cancer Recurrence Determined at 10-week Biopsy. | 7 Participants |
| Genistein Supplement | Number of Participants With Cancer Recurrence Determined at 10-week Biopsy. | 10 Participants |