Vitamin E Supplements in Preventing Cancer in Patients at Risk of Prostate Cancer or Who Have Prostate Cancer

NCT00895115 | Completed Phase 1

• 3 other identifiers: 120802P30CA072720CDR0000639070
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Prostate Cancer

Keywords

prostate cancer

Outcome Measures

Primary Outcomes (3)

• Effect of tocopherol supplementation on plasma and urine levels of α-, γ-, and δ-tocopherols, PSA, and prostaglandin E2

  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)

  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

  4 years

Study Arms (3)

Arm I

SHAM COMPARATOR

Patients receive no supplementation.

Procedure: sham intervention

Arm II

EXPERIMENTAL

Patients receive oral high γ-tocopherol vitamin E supplementation once daily for 1 week.

Dietary Supplement: vitamin E

Arm III

EXPERIMENTAL

Patients receive oral high γ-tocopherol vitamin E supplementation once daily for 2 weeks.

Dietary Supplement: vitamin E

Interventions

vitamin E DIETARY_SUPPLEMENT

Given once daily

Arm II; Arm III

sham intervention PROCEDURE

No supplementation

Arm I

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Medicine and Dentistry of New Jersey: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08903, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Vitamin E

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Susan Goodin, PharmD, FCCP, BCOP

  Rutgers Cancer Institute of New Jersey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2009
• First Posted: May 8, 2009
• Study Start: April 1, 2009
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: June 14, 2012

Record last verified: 2012-06

Locations

US (1)