Vitamin E Supplements in Preventing Cancer in Patients at Risk of Prostate Cancer or Who Have Prostate Cancer
NCT ID: NCT00895115
Last Updated: 2012-06-14
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
PHASE1
65 participants
INTERVENTIONAL
2009-04-30
2012-05-31
Brief Summary
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PURPOSE: This randomized phase I trial is comparing vitamin E supplement regimens to see how well they work in preventing cancer in patients at risk of prostate cancer or who have prostate cancer.
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Detailed Description
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* Determine the effect of tocopherol supplementation on plasma and urine levels of α-, γ-, and δ-tocopherols, PSA, and prostaglandin E\_2 by comparing the blood and urine samples collected before and after the supplementation in patients with prostate cancer.
* Test the hypothesis that the supplementation reduced oxidative and nitrosative stress by measuring plasma levels of F\_2-isoprostane, C-reactive protein, and 3-nitrotyrosine as well as urinary levels of 8-hydroxy-2-deoxyguanosine (8-OHdG).
* Determine the levels of α-, γ-, and δ-tocopherols in prostate tissues and analyze immunohistochemically (IHC) for cell proliferation, apoptosis, cyclooxygenase-2, 8-OHdG, and 3-nitropyrosine levels in prostate cancer/tissue slides.
OUTLINE: Patients are randomized into 1 of 3 arms.
* Arm I: Patients receive no supplementation.
* Arm II: Patients receive oral high γ-tocopherol vitamin E supplementation once daily for 1 week.
* Arm III: Patients receive oral high γ-tocopherol vitamin E supplementation once daily for 2 weeks.
Blood, urine, and tissue samples are collected periodically and analyzed for oxidative/nitrosative stress and other markers (i.e., F2-isoprostane, 8-OHdG, 3-nitrotyrosine, prostaglandin E2, C-reactive protein, and PSA), biomarkers in prostate tumors and nontumorous tissues (i.e., 8-OHdG, 3-nitrotyrosine, and cyclooxygenase-2) by IHC, and pharmacokinetics by high-performance liquid chromatography.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Arm I
Patients receive no supplementation.
sham intervention
No supplementation
Arm II
Patients receive oral high γ-tocopherol vitamin E supplementation once daily for 1 week.
vitamin E
Given once daily
Arm III
Patients receive oral high γ-tocopherol vitamin E supplementation once daily for 2 weeks.
vitamin E
Given once daily
Interventions
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vitamin E
Given once daily
sham intervention
No supplementation
Eligibility Criteria
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Inclusion Criteria
* Meets one of the following criteria:
* Abnormal digital rectal examination or abnormal prostate specific antigen (\> 4.0 ng/mL)
* Obstructing prostate
* Biopsy-proven prostate cancer
* Scheduled to undergo prostate surgery (i.e., transurethral prostatectomy or prostatectomy)
PATIENT CHARACTERISTICS:
* No uncontrolled diabetes, uncontrolled blood pressure, chronic congestive heart failure, or history of renal insufficiency
* No personal or family history of a bleeding disorder
* No known history of problems absorbing dietary fats (e.g., Crohn's disease, cystic fibrosis)
PRIOR CONCURRENT THERAPY:
* More than 2 weeks since prior NSAIDs or corticosteroids
* No concurrent supplementation of vitamin E (a multivitamin containing ≤ 60 IU of vitamin E is allowed)
* No concurrent colestipol or orlistat
* No concurrent warfarin or dicumarol
18 Years
MALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Medicine and Dentistry of New Jersey
OTHER
Responsible Party
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Principal Investigators
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Susan Goodin, PharmD, FCCP, BCOP
Role: PRINCIPAL_INVESTIGATOR
Rutgers Cancer Institute of New Jersey
Locations
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Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
Countries
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Other Identifiers
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CDR0000639070
Identifier Type: OTHER
Identifier Source: secondary_id
120802
Identifier Type: -
Identifier Source: org_study_id
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