Vitamin E Supplements in Preventing Cancer in Patients at Risk of Prostate Cancer or Who Have Prostate Cancer - Full Text View

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:

Genetics Home Reference related topics: prostate cancer

MedlinePlus related topics: Prostate Cancer Vitamin E

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 ( University of Medicine and Dentistry 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 ]
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 ]


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 (Adult, Senior)
Sexes 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

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

National Cancer Institute (NCI)

Investigators


Principal Investigator:	Susan Goodin, PharmD, FCCP, BCOP	Rutgers Cancer Institute of New Jersey

More Information


Responsible Party:	University of Medicine and Dentistry of New Jersey
ClinicalTrials.gov Identifier:	NCT00895115 History of Changes
Other Study ID Numbers:	120802 P30CA072720 ( US NIH Grant/Contract Award Number ) CDR0000639070 ( Other Identifier: NIH )
Study First Received:	May 7, 2009
Last Updated:	June 12, 2012

Keywords provided by Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey ):


prostate cancer

Additional relevant MeSH terms:


Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Vitamins Tocopherols	Vitamin E Tocotrienols alpha-Tocopherol Micronutrients Growth Substances Physiological Effects of Drugs Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents

ClinicalTrials.gov processed this record on June 28, 2017