Trial Outcomes & Findings for Study of Genistein in Reducing Side Effects of Superficial Bladder Cancer Treatment (NCT NCT01489813)
NCT ID: NCT01489813
Last Updated: 2025-02-05
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
36 participants
Primary outcome timeframe
At baseline and after 6 weeks of treatment
Results posted on
2025-02-05
Participant Flow
Participant milestones
| Measure |
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).
|
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).
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
20
|
|
Overall Study
COMPLETED
|
13
|
17
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Genistein in Reducing Side Effects of Superficial Bladder Cancer Treatment
Baseline characteristics by cohort
| Measure |
Sugar Pill
n=16 Participants
Patients will be given placebo pills for 10 weeks.
Sugar pill: Sugar pills will be taken by mouth three times daily (PO TID).
|
Genistein Supplement
n=20 Participants
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).
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
73.2 years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
71.2 years
STANDARD_DEVIATION 8.7 • n=7 Participants
|
71.5 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
20 participants
n=7 Participants
|
36 participants
n=5 Participants
|
|
Number of Participants with Insurance
|
13 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At baseline and after 6 weeks of treatmentThe 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
Outcome measures
| Measure |
Sugar Pill
n=13 Participants
Patients will be given placebo pills for 10 weeks.
Sugar pill: Sugar pills will be taken by mouth three times daily (PO TID).
|
Genistein Supplement
n=17 Participants
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).
|
|---|---|---|
|
Change in Severity of Urinary Symptoms as Determined by the The International Prostate Symptom Score (IPSS) Questionnaire Score.
|
-2 score on a scale
Interval -3.0 to 2.0
|
-3 score on a scale
Interval -4.0 to 2.0
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Sugar Pill
n=14 Participants
Patients will be given placebo pills for 10 weeks.
Sugar pill: Sugar pills will be taken by mouth three times daily (PO TID).
|
Genistein Supplement
n=18 Participants
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).
|
|---|---|---|
|
Number of Participants With Cancer Recurrence Determined at 10-week Biopsy.
|
7 Participants
|
10 Participants
|
Adverse Events
Sugar Pill
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Genistein Supplement
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sugar Pill
n=16 participants at risk
Patients will be given placebo pills for 10 weeks.
Sugar pill: Sugar pills will be taken by mouth three times daily (PO TID).
|
Genistein Supplement
n=20 participants at risk
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).
|
|---|---|---|
|
Infections and infestations
Hospitalization
|
18.8%
3/16 • Number of events 3 • 1 year
|
15.0%
3/20 • Number of events 3 • 1 year
|
|
Renal and urinary disorders
UTI
|
6.2%
1/16 • Number of events 1 • 1 year
|
5.0%
1/20 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Kidney infection
|
0.00%
0/16 • 1 year
|
5.0%
1/20 • Number of events 1 • 1 year
|
|
Surgical and medical procedures
infection after urological surgical procedure
|
6.2%
1/16 • Number of events 1 • 1 year
|
0.00%
0/20 • 1 year
|
|
Infections and infestations
coronovirus
|
0.00%
0/16 • 1 year
|
5.0%
1/20 • Number of events 1 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place