Vitamin E Supplements in Preventing Cancer in Patients at Risk of Prostate Cancer or Who Have Prostate Cancer
This study has been completed.
Sponsor:
University of Medicine and Dentistry of New Jersey
Collaborator:
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
ClinicalTrials.gov Identifier:
NCT00895115
First received: May 7, 2009
Last updated: June 12, 2012
Last verified: June 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Dietary Supplement: vitamin E Procedure: sham intervention |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | A Randomized Study to Investigate the Presence of Tocopherol Metabolites in the Prostate |
Resource links provided by NLM:
Drug Information available for:
alpha-Tocopherol
Tocopherol
alpha-Tocopherol succinate
Tocopherol acetate
dl-alpha-Tocopherol
U.S. FDA Resources
Further study details as provided by Rutgers, The State University of New Jersey:
Primary Outcome Measures:
- Effect of tocopherol supplementation on plasma and urine levels of α-, γ-, and δ-tocopherols, PSA, and prostaglandin E2 [ Time Frame: 4 years ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Enrollment: | 65 |
| Study Start Date: | April 2009 |
| Study Completion Date: | May 2012 |
| Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00895115
Please refer to this study by its ClinicalTrials.gov identifier: NCT00895115
Locations
| United States, New Jersey | |
| Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | |
| New Brunswick, New Jersey, United States, 08903 | |
Sponsors and Collaborators
University of Medicine and Dentistry of New Jersey
Investigators
| Principal Investigator: | Susan Goodin, PharmD, FCCP, BCOP | Rutgers Cancer Institute of New Jersey |
More Information
Additional Information:
No publications provided
| Responsible Party: | Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey ) |
| ClinicalTrials.gov Identifier: | NCT00895115 History of Changes |
| Other Study ID Numbers: | 120802, P30CA072720, CDR0000639070 |
| Study First Received: | May 7, 2009 |
| Last Updated: | June 12, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Rutgers, The State University of New Jersey:
|
prostate cancer |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Diseases, Male Genital Neoplasms, Male Neoplasms Neoplasms by Site Prostatic Diseases Urogenital Neoplasms Alpha-Tocopherol Tocopherols Tocotrienols |
Vitamin E Vitamins Antioxidants Growth Substances Micronutrients Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Protective Agents |
ClinicalTrials.gov processed this record on February 27, 2015