Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
19 participants
INTERVENTIONAL
2018-11-21
2019-12-14
Brief Summary
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Detailed Description
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Aim 1a: Identifying the anti-tumor effects of QC. This will be done by culturing multiple human cancer cell lines with QC at a range of concentrations, followed by readouts at different time points, of tumor cell apoptosis, proliferation, and senescence.
Aim 1b: Identify a hierarchy of tumors that are responsive to QC. From the data in aim one an attempt will be made to identify a hierarchy of anti-tumor effects.
Aim 1c: Investigate the signaling pathways in tumor cells that are modified by QC. To do this, full genomic profiling will be conducted for breast and prostate tumor cell lines, and will be done in conjunction with analysis of the relevant signaling pathways, and will include P53 and P21 activation pathways.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Intervention
Daily Fermented Soy (two 12.5g packets/day) (\~1 ounce/day) taken between the time of enrollment and radical prostatectomy (RP). Clinical assessment of both groups will take place 1) at baseline, and 2) just prior to RP, estimated at between 4 and 10 weeks from baseline/enrollment. Length of time in the study will vary for each subject, depending on how far out their prostatectomy will occur; all prostatectomies will be scheduled to occur between 4-10 weeks post-baseline.
Fermented Soy
Two 12.5g packets/day) (\~1 ounce/day) taken between the time of enrollment and radical prostatectomy (RP). Time can be between 4 and 10 weeks.
Placebo
Daily (matched dose) taken between the time of enrollment and radical prostatectomy (RP). Clinical assessment of both groups will take place 1) at baseline, and 2) just prior to RP, estimated at between 4 and 10 weeks from baseline/enrollment. Length of time in the study will vary for each subject, depending on how far out their prostatectomy will occur; all prostatectomies will be scheduled to occur between 4-10 weeks post-baseline.
Placebo
A placebo compliment to the active intervention with identical packaging and labeling will be used.
Interventions
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Fermented Soy
Two 12.5g packets/day) (\~1 ounce/day) taken between the time of enrollment and radical prostatectomy (RP). Time can be between 4 and 10 weeks.
Placebo
A placebo compliment to the active intervention with identical packaging and labeling will be used.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Scheduled to be treated by radical prostatectomy within the next 4-10 weeks
* Understanding and willingness to provide consent
Exclusion Criteria
* History of hormone dependent malignancies
* Concomitant thyroid disease or currently taking thyroid hormone replacement medication
* Current high-dose soy consumption, micronutrient, or herbal supplements, on soy or vegetarian nutrition, or any other extreme dietary habits
* Current or past history of any liver or pancreas disease
* History of allergy or hypersensitivity to soy-containing products
* Malabsorption conditions that might interfere with absorption of the investigational product
18 Years
MALE
No
Sponsors
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Yale University
OTHER
Responsible Party
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Locations
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Yale University
New Haven, Connecticut, United States
Yale New Haven Health- Lawrence + Memorial Hospital
New London, Connecticut, United States
South County Hospital
Wakefield, Rhode Island, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2000020868
Identifier Type: -
Identifier Source: org_study_id
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