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Alpha-Tocopherol, Beta-Carotene Cancer Prevention (ATBC) Study

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Institute for Health and Welfare, Finland
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00342992
First received: June 19, 2006
Last updated: October 19, 2012
Last verified: October 2012
History of Changes
  Purpose

The Alpha-Tocopherol Beta-Carotene Cancer Prevention (ATBC) Study was a large randomized, double-blind, placebo-controlled, 2x2 factorial design, primary prevention trial testing the effects of alpha-tocopherol and beta-carotene supplements on cancer incidence and mortality conducted in Finland as a collaboration between the Public Health Institute (KTL) of Finland and the U.S. National Cancer Institute. The intervention period ended in 1993, and the research project was continued as a passive follow-up of participants during the post-intervention period to monitor potential intervention effects on cancers, as well as other morbidity and mortality endpoints. The cohort follow-up serves as a basis for cancer epidemiological research of a wide range of cancer risk factors, biomarkers, and genetic predisposition based on data and biologic samples collected during the study. This research is aimed at testing hypotheses relevant to cancer prevention, etiology, and early detection, and the study material provide an invaluable resource for the study of dietary, biochemical and molecular hypotheses. The analyses are made particularly informative in that nearly 20 years of follow-up are available for study.


Condition Intervention
Lung Cancer
Prostatic Neoplasms
Prostate Cancer
Pancreatic Cancer
 Drug: beta-carotene supplements
Drug: alpha-tocopherol supplements

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Alpha-Tocopherol, Beta-Carotene Lung Cancer Prevention Study (ATBC Study) Population

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Incidence of and mortality from lung cancer during intervention (ended April 1993) and post-intervention.

Secondary Outcome Measures:
  • Other cancers, Major coronary disease, Stroke, Diabetes, Dementia, Symptoms of angina pectoris, intermittent claudicatin and chronic obstructive pulmonary disease

Estimated Enrollment: 25000
Study Start Date: August 1985
Intervention Details:
    Drug: beta-carotene supplements
    N/A
    Drug: alpha-tocopherol supplements
    N/A
Detailed Description:

The ATBC study was a randomized, double-blind, placebo-controlled, primary prevention trial to determine whether daily supplementation with a-tocopherol, (Beta)-carotene, or both would reduce the incidence of lung or other cancers among male smokers. Between 1985 and 1988, 29,133 men ages 50 to 69 years, who smoked at least five cigarettes per day, were recruited from southwestern Finland. Participants were randomly assigned to receive either a-tocopherol as dl-a-tocopheryl acetate (50 mg/day), (Beta)-carotene as all-trans-(Beta)-carotene (20 mg/day), both supplements, or placebo capsules for 5-8 years (median 6.1 years) through April 30, 1993. Post-intervention follow-up has continued through the Finnish Cancer Registry and other national registries, and epidemiological analyses continue to be conducted.

  Eligibility

Ages Eligible for Study:   50 Years to 69 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

Current smokers (five or more cigarettes per day at study entry) from Southwestern Finland.

EXCLUSION CRITERIA:

  • Females
  • Proven malignancy (except nonmelanoma skin cancer or cancer in situ)
  • Severe angina pectoris
  • Chronic renal insufficiency
  • Cirrhosis of the liver
  • Chronic alcoholism
  • Anticoagulant therapy
  • Use of supplements containing vitamin E greater than 20 mg/day, or vitaming A greater than 20,000 IU/day, or beta-carotene greater than 6 mg/day
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00342992

Locations
Finland
National Public Health Institute
Helsinki, Finland
Sponsors and Collaborators
National Cancer Institute (NCI)
National Institute for Health and Welfare, Finland
Investigators
Principal Investigator: Demetrius A Albanes, M.D. National Cancer Institute (NCI)
  More Information

Publications:

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

ClinicalTrials.gov Identifier: NCT00342992     History of Changes
Other Study ID Numbers: 999995012, OH95-C-N012
Study First Received: June 19, 2006
Last Updated: October 19, 2012
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Alpha-tocopherol (vitamin E)
Beta-carotene
Lung Neoplasms
 Cardiovascular Disease
Diabetes
Randomized controlled trials

Additional relevant MeSH terms:
Neoplasms
Lung Neoplasms
Pancreatic Neoplasms
Prostatic Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Genital Neoplasms, Male
 Urogenital Neoplasms
Genital Diseases, Male
Prostatic Diseases
Carotenoids
Alpha-Tocopherol
Vitamin E
Tocopherols
Tocotrienols
Beta Carotene
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Vitamins

ClinicalTrials.gov processed this record on June 18, 2013