Physicians' Health Study
- From: J <nexsw@nvalid,anon>
- Date: Wed, 16 May 2007 04:56:35 -0400
Physicians' Health Study
http://phs.bwh.harvard.edu/
Welcome to the Web site of the Physicians' Health Study. This landmark
study was begun in the fall of 1982 to test the benefits and risks of
aspirin and beta-carotene in the primary prevention of cardiovascular
disease and cancer. Twenty-four years and more than 200 published research
reports later, it is still going strong.
The original randomized trial, the Physicians' Health Study-I, ended in
1995. Its finding that daily low-dose aspirin decreased the risk of a
first myocardial infarction by 44% Pill packs around the globe helped
focus on the role of aspirin in primary prevention. It also showed no
benefit or harm from beta-carotene, a finding that allowed investigators
to turn to other, more promising agents. Although that trial may be over,
the physicians who took part in it continue to help advance our knowledge
about the prevention of cardiovascular disease, cancer, and other chronic
diseases by completing annual questionnaires. Dedicated PHS participants
took the study, and their study pills, to almost every part of the globe.
A second randomized trial, the Physicians' Health Study-II, is now testing
the balance of benefits and risks of three other widely used, but as yet
unproven, supplements for the primary prevention of cardiovascular
disease, cancer, and age-related eye disease--vitamin E, vitamin C, and a
multivitamin.
http://clinicaltrials.gov/ct/show/NCT00270647
Physicians' Health Study II: Vitamin E, Ascorbic Acid, Beta Carotene,
and/or Multivitamins in Preventing Cancer and Cardiovascular Disease in
Older Healthy Male Doctors
This study is no longer recruiting patients.
Sponsors and Collaborators: Dana-Farber Cancer Institute
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00270647
RATIONALE: Chemoprevention is the use of certain drugs or nutritional
supplements to keep cancer from forming, growing, or coming back. The use
of vitamin E, ascorbic acid, beta carotene, and/or multivitamins may keep
cancer or other diseases, such as cardiovascular disease, from forming.
PURPOSE: This randomized clinical trial is studying vitamin E, ascorbic
acid, beta carotene, and/or multivitamins to see how well they work
compared to placebos in preventing prostate cancer, other cancers, or
cardiovascular disease in healthy older male doctors. NOTE: Beta carotene
was no longer given as of 3/8/2003.
Colorectal Cancer
Prostate Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Drug: ascorbic acid
Drug: beta carotene
Drug: multivitamin
Drug: vitamin E
Procedure: biologically based therapies
Procedure: cancer prevention intervention
Procedure: chemoprevention of cancer
Procedure: complementary and alternative therapy
Procedure: dietary intervention
Procedure: nutritional supplementation
Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control
Official Title: Physicians' Health Study II: Trial of Vitamins in the
Chemoprevention of Cancer, CVD, and Eye Disease
Further study details as provided by National Cancer Institute (NCI):
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.
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.)
PROJECTED ACCRUAL: A total of 14,661 participants were accrued for this
study.
* Healthy male physician practicing in the United States
* Prior participation in the Physicians' Health Study I allowed
PATIENT CHARACTERISTICS:
Age * 50 and over
* 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
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Study ID Numbers: CDR0000448630; BWH-1999-P-003315; BWH-1999-P-003318;
BWH-83-00405
Last Updated: March 5, 2007
Record first received: December 27, 2005
ClinicalTrials.gov Identifier: NCT00270647
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on May 14, 2007
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