Status:
COMPLETED
Carotene and Retinol Efficacy Trial
Lead Sponsor:
Fred Hutchinson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lung Cancer
Eligibility:
All Genders
45-69 years
Phase:
PHASE4
Brief Summary
The Carotene and Retinol Efficacy Trial (CARET) was a randomized, double-blind, placebo-controlled trial of the cancer prevention efficacy and safety of a daily combination of 30 mg of beta-carotene a...
Eligibility Criteria
Inclusion
- Asbestos-exposed men who were:
- current smokers or quit within 15 years prior to enrollment
- had first exposure to asbestos on the job at least 15 years prior to enrollment
- had chest X-ray positive for changes compatible with asbestos exposure according to ILO criteria; or had been employed in a protocol-defined high-risk trade for at least 5 years, at least 10 years prior to enrollment.
- Heavy Smokers, men and women:
- cigarette smoking history of 20+ pack-years
- either current smokers or had quit within previous 6 years
Exclusion
- Pre-menopausal women
- History or cirrhosis or hepatitis within 12 months prior to enrollment
- Taking \> 5500 IU daily vitamin A supplement
- Taking any beta-carotene supplement
- History of cancer within 5 years prior to enrollment
- SGOT \> than 2.5X upper limit of normal, or alkaline phosphatase \> 1.5X upper limit of normal
- taking less than 50% of study vitamins during the enrollment period between the First and Second Visits.
Key Trial Info
Start Date :
May 1 1985
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2005
Estimated Enrollment :
18314 Patients enrolled
Trial Details
Trial ID
NCT00712647
Start Date
May 1 1985
End Date
June 1 2005
Last Update
September 26 2012
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