Status:
COMPLETED
Vitamin E Supplements in Preventing Cancer in Patients at Risk of Prostate Cancer or Who Have Prostate Cancer
Lead Sponsor:
University of Medicine and Dentistry of New Jersey
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE1
Brief Summary
RATIONALE: Vitamin E supplements may stop or delay the development of prostate cancer in patients who are at risk of prostate cancer or who have prostate cancer. It is not yet known which vitamin E re...
Detailed Description
OBJECTIVES: * 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 collecte...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT00895115
Start Date
April 1 2009
End Date
May 1 2012
Last Update
June 14 2012
Active Locations (1)
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1
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903