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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 ongoing, but not recruiting participants.

Sponsors and Collaborators: Dana-Farber/Brigham and Women's Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
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
Drug: ascorbic acid
Drug: beta carotene
Drug: multivitamin
Drug: vitamin E

Genetics Home Reference related topics:   Benign Tumors   Cancer   Colorectal Cancer  

MedlinePlus related topics:   Cancer   Colorectal Cancer   Prostate Cancer  

ChemIDplus related topics:   Vitamin E   alpha-Tocopherol   alpha-Tocopheryl acetate   Tocopherols   Ascorbic acid   Carotenoids   beta Carotene  

U.S. FDA Resources

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):

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
Dana-Farber/Brigham and Women's Cancer Center
National Cancer Institute (NCI)

Investigators
Study Chair:     J. Michael Gaziano, MD, MPH     Dana-Farber/Brigham and Women's Cancer Center    
  More Information

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

Publications indexed to this study:

Study ID Numbers:   CDR0000448630, BWH-1999-P-003315, BWH-1999-P-003318, BWH-83-00405
First Received:   December 27, 2005
Last Updated:   May 23, 2008
ClinicalTrials.gov Identifier:   NCT00270647
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
prostate cancer  
colon cancer  
unspecified adult solid tumor, protocol specific  

Study placed in the following topic categories:
Beta Carotene
Tocopherol acetate
Digestive System Neoplasms
Genital Neoplasms, Male
Prostatic Diseases
Gastrointestinal Diseases
Colonic Diseases
Urogenital Neoplasms
Healthy
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Alpha-Tocopherol
Tocopherols
Vitamin E
Gastrointestinal Neoplasms
Prostatic Neoplasms
Carotenoids
Ascorbic Acid
Colorectal Neoplasms

Additional relevant MeSH terms:
Neoplasms
Antioxidants
Digestive System Diseases
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Growth Substances
Vitamins
Physiological Effects of Drugs
Micronutrients
Genital Diseases, Male
Protective Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 03, 2008




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