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: March 14, 2014
Last verified: September 2013

June 19, 2006
March 14, 2014
August 1985
Not Provided
Incidence of and mortality from lung cancer during intervention (ended April 1993) and post-intervention.
Not Provided
Complete list of historical versions of study NCT00342992 on ClinicalTrials.gov Archive Site
Other cancers, Major coronary disease, Stroke, Diabetes, Dementia, Symptoms of angina pectoris, intermittent claudicatin and chronic obstructive pulmonary disease
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Alpha-Tocopherol, Beta-Carotene Cancer Prevention (ATBC) Study
Alpha-Tocopherol, Beta-Carotene Lung Cancer Prevention Study (ATBC Study) Population

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.

The ATBC study was a randomized, double-blind, placebo-controlled, primary prevention trial to determine whether daily supplementation with a-tocopherol, (SqrRoot) -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), (SqrRoot) -carotene as all-trans-(SqrRoot) -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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double-Blind
Primary Purpose: Prevention
  • Lung Cancer
  • Prostatic Neoplasms
  • Prostate Cancer
  • Pancreatic Cancer
  • Drug: beta-carotene supplements
    N/A
  • Drug: alpha-tocopherol supplements
    N/A
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
25000
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  • 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
Male
50 Years to 69 Years
No
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT00342992
999995012, OH95-C-N012
Not Provided
Not Provided
National Cancer Institute (NCI)
National Institute for Health and Welfare, Finland
Principal Investigator: Demetrius A Albanes, M.D. National Cancer Institute (NCI)
National Institutes of Health Clinical Center (CC)
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP