Vitamin E Supplements in Preventing Cancer in Patients at Risk of Prostate Cancer or Who Have Prostate Cancer
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ClinicalTrials.gov Identifier: NCT00895115 |
Recruitment Status :
Completed
First Posted : May 8, 2009
Last Update Posted : June 14, 2012
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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 regimen is more effective in preventing prostate cancer.
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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Prostate Cancer | Dietary Supplement: vitamin E Procedure: sham intervention | Phase 1 |
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 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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 65 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | A Randomized Study to Investigate the Presence of Tocopherol Metabolites in the Prostate |
Study Start Date : | April 2009 |
Actual Primary Completion Date : | May 2012 |
Actual Study Completion Date : | May 2012 |

Arm | Intervention/treatment |
---|---|
Sham Comparator: Arm I
Patients receive no supplementation.
|
Procedure: sham intervention
No supplementation |
Experimental: Arm II
Patients receive oral high γ-tocopherol vitamin E supplementation once daily for 1 week.
|
Dietary Supplement: vitamin E
Given once daily |
Experimental: Arm III
Patients receive oral high γ-tocopherol vitamin E supplementation once daily for 2 weeks.
|
Dietary Supplement: vitamin E
Given once daily |
- Effect of tocopherol supplementation on plasma and urine levels of α-, γ-, and δ-tocopherols, PSA, and prostaglandin E2 [ Time Frame: 4 years ]
- Oxidative stress and nitrosative stress as assessed by plasma levels of F2-isoprostane, C-reactive protein, and 3-nitrotyrosine as well as urinary levels of 8-hydroxy-2-deoxyguanosine (8-OHdG) [ Time Frame: 4 years ]
- Levels of α-, γ-, and δ-tocopherols in prostate tissues and cell proliferation, apoptosis, cyclooxygenase-2, 8-OHdG, and 3-nitropyrosine levels as assessed by IHC [ Time Frame: 4 years ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00895115
United States, New Jersey | |
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | |
New Brunswick, New Jersey, United States, 08903 |
Principal Investigator: | Susan Goodin, PharmD, FCCP, BCOP | Rutgers Cancer Institute of New Jersey |
Responsible Party: | University of Medicine and Dentistry of New Jersey |
ClinicalTrials.gov Identifier: | NCT00895115 |
Other Study ID Numbers: |
120802 P30CA072720 ( U.S. NIH Grant/Contract ) CDR0000639070 ( Other Identifier: NIH ) |
First Posted: | May 8, 2009 Key Record Dates |
Last Update Posted: | June 14, 2012 |
Last Verified: | June 2012 |
prostate cancer |
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Prostatic Diseases Vitamin E |
Vitamins Micronutrients Physiological Effects of Drugs Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents |