Physicians' Health Study II: Vitamin E, Ascorbic Acid, Beta Carotene, and/or Multivitamins in Preventing Cancer and Cardiovascular Disease in Older Healthy Male Doctors - Full Text View

Sponsor:	Brigham and Women's Hospital
Collaborator:	National Cancer Institute (NCI)
Information provided by:	Brigham and Women's Hospital
ClinicalTrials.gov Identifier:	NCT00270647

Purpose

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.

Condition	Intervention
Colorectal Cancer Prostate Cancer Unspecified Adult Solid Tumor, Protocol Specific	Dietary Supplement: ascorbic acid Dietary Supplement: beta carotene Dietary Supplement: multivitamin Dietary Supplement: vitamin E

Study Type:	Interventional
Study Design:	Allocation: Randomized Masking: Double-Blind Primary Purpose: Prevention
Official Title:	Physicians' Health Study II: Trial of Vitamins in the Chemoprevention of Cancer, CVD, and Eye Disease

Resource links provided by NLM:

MedlinePlus related topics: Cancer Colorectal Cancer Prostate Cancer Vitamin C Vitamin E

Drug Information available for: Carotenoids Ascorbic acid alpha-Tocopherol DL-alpha-Tocopherol Vitamin E Tocopherols Tocotrienol beta Carotene

U.S. FDA Resources

Further study details as provided by Brigham and Women's Hospital:

Study Start Date:	June 2009
Estimated Study Completion Date:	June 2011
Estimated Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

DISEASE CHARACTERISTICS:

Healthy male physician practicing in the United States
Prior participation in the Physicians' Health Study I allowed

PATIENT CHARACTERISTICS:

Age

50 and over

Performance status

Not specified

Life expectancy

Not specified

Hematopoietic

Not specified

Hepatic

No history of liver disease

Renal

Not specified

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

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

Not specified

Endocrine therapy

Not specified

Radiotherapy

Not specified

Surgery

Not specified

Other

No other concurrent vitamin and/or multivitamin supplementation
No concurrent vitamin K-depleting anticoagulants (e.g., warfarin)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00270647

Sponsors and Collaborators

Brigham and Women's Hospital

National Cancer Institute (NCI)

Investigators

Study Chair:

J. Michael Gaziano, MD, MPH

Dana-Farber/Brigham and Women's Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Gaziano JM, Glynn RJ, Christen WG, Kurth T, Belanger C, MacFadyen J, Bubes V, Manson JE, Sesso HD, Buring JE. Vitamins E and C in the prevention of prostate and total cancer in men: the Physicians' Health Study II randomized controlled trial. JAMA. 2009 Jan 7;301(1):52-62. Epub 2008 Dec 9.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Christen WG, Glynn RJ, Sesso HD, Kurth T, MacFadyen J, Bubes V, Buring JE, Manson JE, Gaziano JM. Age-related cataract in a randomized trial of vitamins E and C in men. Arch Ophthalmol. 2010 Nov;128(11):1397-405.

Sesso HD, Buring JE, Christen WG, Kurth T, Belanger C, MacFadyen J, Bubes V, Manson JE, Glynn RJ, Gaziano JM. Vitamins E and C in the prevention of cardiovascular disease in men: the Physicians' Health Study II randomized controlled trial. JAMA. 2008 Nov 12;300(18):2123-33. Epub 2008 Nov 9.

Grodstein F, Kang JH, Glynn RJ, Cook NR, Gaziano JM. A randomized trial of beta carotene supplementation and cognitive function in men: the Physicians' Health Study II. Arch Intern Med. 2007 Nov 12;167(20):2184-90.

Responsible Party:	J. Michael Gaziano, MD, MPH, Brigham & Women's Hospital
ClinicalTrials.gov Identifier:	NCT00270647 History of Changes
Other Study ID Numbers:	CDR0000448630, BWH-1999-P-003315, BWH-1999-P-003318, BWH-83-00405
Study First Received:	December 27, 2005
Last Updated:	May 3, 2010
Health Authority:	United States: Federal Government

Keywords provided by Brigham and Women's Hospital:

prostate cancer
colon cancer
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:

Cardiovascular Diseases
Colorectal Neoplasms
Prostatic Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Genital Neoplasms, Male
Urogenital Neoplasms

Genital Diseases, Male
Prostatic Diseases
Ascorbic Acid
Carotenoids
Vitamin E
Alpha-Tocopherol
Tocopherols
Tocotrienols
Vitamins
Beta Carotene
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012