Overview

This trial is active, not recruiting.

Conditions stroke, diabetes mellitus, heart disease, cancer
Sponsor National Cancer Institute (NCI)
Collaborator National Institute for Health and Welfare, Finland
Start date August 1985
Trial size 29133 participants
Trial identifier NCT00342992, 999995012, OH95-C-N012

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Time perspective prospective

Primary Outcomes

Measure
Cancer
time frame: Annually

Secondary Outcomes

Measure
Causes of Mortality
time frame: Annually

Eligibility Criteria

Male participants from 50 years up to 69 years old.

- 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

Additional Information

Official title Alpha-Tocopherol, Beta-Carotene Lung Cancer Prevention Study (ATBC Study) Population
Principal investigator Demetrius A Albanes, M.D.
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by National Institutes of Health Clinical Center (CC).