Soy Supplements in Treating Patients Undergoing Surgery for Localized Prostate Cancer
NCT ID: NCT00345813
Last Updated: 2018-08-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
62 participants
INTERVENTIONAL
2003-10-31
2006-07-31
Brief Summary
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PURPOSE: This randomized phase II trial is studying a soy supplement to see how well it works compared to a placebo in treating patients undergoing surgery for localized prostate cancer.
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Detailed Description
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Primary
* Compare the effect of dietary supplementation with soy vs placebo on biomarkers of cell cycle regulation, proliferation, differentiation, apoptosis, and signaling pathways in patients with localized prostate cancer scheduled to undergo radical prostatectomy.
Secondary
* Compare the toxicity and side effects of these regimens in these patients.
* Compare the dietary patterns of these patients.
OUTLINE: This is a prospective, randomized study. Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive oral soy supplementation daily for 4 weeks.
* Arm II: Patients receive oral placebo supplementation daily for 4 weeks. Patients undergo radical prostatectomy within 21 days after completion of soy or placebo supplementation.
Blood and tissue samples are collected for biomarker analysis using immunohistochemistry.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Arm I
Patients receive oral soy supplementation daily for 4 weeks. Patients undergo radical prostatectomy within 21 days after completion of soy supplementation.
soy isoflavones
Given orally
soy protein isolate
Given orally
Arm II
Patients receive oral placebo supplementation daily for 4 weeks. Patients undergo radical prostatectomy within 21 days after completion of placebo supplementation.
placebo
Given orally
Interventions
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soy isoflavones
Given orally
soy protein isolate
Given orally
placebo
Given orally
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed adenocarcinoma of the prostate
* Clinically localized disease
* Scheduled for radical prostatectomy
* No evidence of metastatic disease by bone scan or CT scan of the abdomen or pelvis
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* No evidence of active nephrolithiasis
* No history of hypercalcemic syndrome
PRIOR CONCURRENT THERAPY:
* No prior treatment for prostate cancer, including radiotherapy, systemic chemotherapy, surgery, or investigational drugs
* No other concurrent dietary supplementation with soy, cholecalciferol (vitamin D), or fish oil
18 Years
120 Years
MALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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M. Craig Hall, MD
Role: STUDY_CHAIR
Wake Forest University Health Sciences
Locations
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Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States
Countries
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Other Identifiers
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CCCWFU-98203
Identifier Type: -
Identifier Source: secondary_id
CCCWFU-BG03-332
Identifier Type: -
Identifier Source: secondary_id
CDR0000466317
Identifier Type: -
Identifier Source: org_study_id
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