Trial · NCT01489813
Study of Genistein in Reducing Side Effects of Superficial Bladder Cancer Treatment
NCT01489813, Phase 2, Completed, Emory University; results first posted 2024-07-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Genistein in Reducing Side Effects of Superficial Bladder Cancer Treatment. Trials, record NCT01489813. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01489813
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Genistein in Reducing Side Effects of Superficial Bladder Cancer Treatment
- NCT number
- NCT01489813
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 36 participants, actual
- Lead sponsor
- Emory University
- Conditions
- Bladder Cancer
- Interventions
- Genistein, Sugar pill
- First posted
- 2011-12-12
- Last updated
- 2025-02-05
- Results first posted
- 2024-07-25
- Limitations and caveats
Actual enrollment was 36 subjects as reflected in the study data. Accrual did not meet the projected enrollment number due to lack of interest amongst patients and insufficient population within clinic.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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 | score on a scale | MEDIAN | |
| SECONDARY | Number of Participants With Cancer Recurrence Determined at 10-week Biopsy. | At 10 weeks of treatment. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Severity of Urinary Symptoms as Determined by the The International Prostate Symptom Score (IPSS) Questionnaire Score. | Sugar Pill | -2 | Full Range -3 to 2 | score on a scale | |
| Change in Severity of Urinary Symptoms as Determined by the The International Prostate Symptom Score (IPSS) Questionnaire Score. | Genistein Supplement | -3 | Full Range -4 to 2 | score on a scale | |
| Number of Participants With Cancer Recurrence Determined at 10-week Biopsy. | Sugar Pill | 7 | Participants | ||
| Number of Participants With Cancer Recurrence Determined at 10-week Biopsy. | Genistein Supplement | 10 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sugar Pill | 16 | |
| Overall Study | STARTED | Genistein Supplement | 20 | |
| Overall Study | COMPLETED | Sugar Pill | 13 | |
| Overall Study | COMPLETED | Genistein Supplement | 17 | |
| Overall Study | NOT COMPLETED | Sugar Pill | 3 | |
| Overall Study | NOT COMPLETED | Genistein Supplement | 3 |
Source ClinicalTrials.gov
Adverse events10
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Hospitalization | Infections and infestations | Sugar Pill | 3 | 16 | 3 |
| other | Hospitalization | Infections and infestations | Genistein Supplement | 3 | 20 | 3 |
| other | UTI | Renal and urinary disorders | Sugar Pill | 1 | 16 | 1 |
| other | UTI | Renal and urinary disorders | Genistein Supplement | 1 | 20 | 1 |
| other | Kidney infection | Renal and urinary disorders | Sugar Pill | 0 | 16 | 0 |
| other | Kidney infection | Renal and urinary disorders | Genistein Supplement | 1 | 20 | 1 |
| other | infection after urological surgical procedure | Surgical and medical procedures | Sugar Pill | 1 | 16 | 1 |
| other | infection after urological surgical procedure | Surgical and medical procedures | Genistein Supplement | 0 | 20 | 0 |
| other | coronovirus | Infections and infestations | Sugar Pill | 0 | 16 | 0 |
| other | coronovirus | Infections and infestations | Genistein Supplement | 1 | 20 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sugar Pill | 0 | 16 |
| Total, all-cause mortality | Genistein Supplement | 0 | 20 |
| Total, other adverse events | Sugar Pill | 3 | 16 |
| Total, other adverse events | Genistein Supplement | 3 | 20 |
| Total, serious adverse events | Sugar Pill | 0 | 16 |
| Total, serious adverse events | Genistein Supplement | 0 | 20 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA138292 | Winship Cancer Institute Cancer Center Support Grant | RAMALINGAM, SURESH S | EMORY UNIVERSITY | NATIONAL CANCER INSTITUTE | 2009 to 2025 |
Source NIH RePORTER
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Sugar Pill vs Genistein Supplement: Number of Participants With Cancer Recurrence Determined at 10-week Biopsy. | Trial comparisons |
| Sugar Pill vs Genistein Supplement: deaths from any cause | Trial comparisons |
| Sugar Pill vs Genistein Supplement: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01489813
GET https://conductscience.org/api/trials/v1/NCT01489813/registered