Carotene and Retinol Efficacy Trial
Information source: Fred Hutchinson Cancer Research Center
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Lung Cancer
Intervention: Beta Carotene and Retinol (Drug); Placebo (Other)
Phase: Phase 4
Status: Completed
Sponsored by: Fred Hutchinson Cancer Research Center Official(s) and/or principal investigator(s): Gary E Goodman, MD, Principal Investigator, Affiliation: Fred Hutchinson Cancer Research Center
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 and 25,000 IU of retinyl palmitate in 18,314 persons at high risk
for lung cancer. CARET began in 1985, and the intervention was halted in January 1996, 21
months ahead of schedule, with the twin conclusions for definitive evidence of no benefit
and substantial evidence of a harmful effect of the intervention on both lung cancer
incidence and total mortality. CARET continued to follow and collect endpoints on their
participants through 2005. During the active intervention phase of CARET, serum, plasma,
whole blood, and lung tissue specimens were collected on participants. These biospecimens
make up the CARET Biorepository.
The CARET Biorepository is a valuable resource for population-based studies of the major
human cancers. During CARET's twenty years of follow-up (1985-2005), we have received
reports of 1,445 participants with lung cancer, 901 with prostate cancer, 433 with breast
cancer, 334 with bladder cancer, 332 with colon cancer, and 1,429 with other cancers. CARET
is one of the few trials that has prospectively collected serum, plasma, whole blood, blood
spots (for DNA), and lung cancer tumor specimens, as well as smoking history and serial food
frequency questionnaires (in some individuals for up to 12 years) in populations at high
risk for lung cancer. This wealth of information in over 18,000 individuals makes the CARET
Biorepository a special resource for cancer researchers.
Clinical Details
Official title: Caret and Retinol Efficacy Trial: The Caret Coordinating Center
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: Lung Cancer Incidence
Secondary outcome: Other cancers
Eligibility
Minimum age: 45 Years.
Maximum age: 69 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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.
Locations and Contacts
Additional Information
Starting date: May 1985
Last updated: September 25, 2012
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