 |
Clinical Trial Questions?
|
|
|
Physicians' Health Study II: Vitamin E, Ascorbic Acid, Beta Carotene,
and/or Multivitamins in Preventing Cancer and Cardiovascular Disease in
Older Healthy Male Physicians
Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information
Alternate Title
Physicians' Health Study II: Vitamin E, Ascorbic Acid, Beta Carotene, and/or Multivitamins in Preventing Cancer and Cardiovascular Disease in Older Healthy Male Doctors
Basic Trial Information
| Phase | Type | Status | Age | Protocol IDs |
|---|
| No phase specified | Prevention | Closed | 50 and over | BWH-1999-P-003315
BWH-1999-P-003318, BWH-83-00405, NCT00270647 |
Objectives Primary - Determine whether vitamin E every other day reduces the risk of developing prostate cancer in older healthy male physicians.
- Determine whether daily ascorbic acid and/or a multivitamin reduces the risk of total cancer in these participants.
- Determine whether vitamin E every other day, ascorbic acid daily, or a multivitamin daily reduces the risk of important vascular events in these participants (beta carotene portion of study discontinued as of 3/8/2003).
Secondary - Determine whether vitamin E and/or multivitamins reduce the risk of developing total cancer, colon cancer, and colon polyps in these participants.
- Determine whether vitamin E, ascorbic acid, or multivitamins reduce the risk of myocardial infarction and stroke in these participants.
- Determine whether vitamin E, ascorbic acid, or multivitamins reduce the risk of age-related macular degeneration or cataract in these participants.
- Determine whether vitamin E, ascorbic acid, or multivitamins reduce the risk of early cognitive decline in men aged 65 and over.
Entry Criteria Disease Characteristics:
- Healthy male physician practicing in the United States
- Prior participation in the Physicians' Health Study I allowed
Prior/Concurrent Therapy:
Biologic therapy Chemotherapy Endocrine therapy Radiotherapy Surgery Other - No other concurrent vitamin and/or multivitamin supplementation
- No concurrent vitamin K-depleting anticoagulants (e.g., warfarin)
Patient Characteristics:
Age Performance status Life expectancy Hematopoietic Hepatic - No history of liver disease
Renal Other - No history of other serious illness that would preclude study participation
- No history of significant adverse events (e.g., rash or allergic reaction) attributed to study agents
Expected Enrollment A total of 14,661 participants were accrued for this study. Outline This is a randomized, double-blind, placebo-controlled study. - Pre-randomization run-in phase: Participants who did not participate in the Physicians' Health Study I (PHS I) receive vitamin E placebo once every other day, ascorbic acid placebo once daily, multivitamin placebo once daily, and beta carotene placebo once every other day for 12 weeks. Participants demonstrating compliance with pill taking proceed, along with participants who participated in PHS I, to the randomized phase. (Beta carotene portion of study discontinued as of 3/8/2003.)
- Randomized phase: Participants are randomized to receive all active supplements, all placebos, or any combination comprising oral vitamin E or placebo once every other day, oral ascorbic acid or placebo once daily, oral multivitamin or placebo once daily, and/or oral beta carotene or placebo once every other day for 4 years. (Beta carotene portion of study discontinued as of 3/8/2003.)
Published ResultsGaziano JM, Glynn RJ, Christen WG, et al.: Vitamins E and C in the prevention of prostate and total cancer in men: the Physicians' Health Study II randomized controlled trial. JAMA 301 (1): 52-62, 2009.[PUBMED Abstract]
Trial Contact Information
Trial Lead Organizations Dana-Farber/Brigham and Women's Cancer Center | | | | J. Michael Gaziano, MD, MPH, Protocol chair | | | |
| Registry Information | | | Official Title | | Physicians' Health Study II: Trial of Vitamins in the Chemoprevention of Cancer, CVD, and Eye Disease | | | Registered in ClinicalTrials.gov | | NCT00270647 | | | Date Submitted to PDQ | | 2005-09-09 | | | Information Last Verified | | 2006-01-03 | | | NCI Grant/Contract Number | | CA097193 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.  Back to Top |
|
