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Sponsors and Collaborators: |
Fred Hutchinson Cancer Research Center National Cancer Institute (NCI) |
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Information provided by: | Fred Hutchinson Cancer Research Center |
ClinicalTrials.gov Identifier: | NCT00712647 |
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.
Condition | Intervention | Phase |
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Lung Cancer |
Dietary Supplement: Beta Carotene and Retinol Other: Placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Caret and Retinol Efficacy Trial: The Caret Coordinating Center |
Enrollment: | 18314 |
Study Start Date: | May 1985 |
Estimated Study Completion Date: | December 2018 |
Primary Completion Date: | December 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Asbestos-exposed participants and heavy smokers
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Dietary Supplement: Beta Carotene and Retinol
Pilot participants (ppts): Asbestos-Exposed--15 mg/day beta-carotene + 25,000 IU/day retinol Heavy Smokers--30 mg/day beta-carotene + 25,000 IU/day retinol Vanguard & Efficacy ppts: Asbestos-exposed AND heavy smokers--30 mg/day beta-carotene + 25,000 IU/day retinol |
2: Placebo Comparator
Asbestos-exposed participants and heavy smokers
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Other: Placebo
Two placebos, one each/day
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Ages Eligible for Study: | 45 Years to 69 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Asbestos-exposed men who were:
Heavy Smokers, men and women:
Exclusion Criteria:
Responsible Party: | Fred Hutchinson Cancer Research Center ( Gary Goodman, MD ) |
Study ID Numbers: | FHRCR IR-4239A, UO1 CA63673 |
Study First Received: | July 8, 2008 |
Last Updated: | July 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00712647 History of Changes |
Health Authority: | United States: Food and Drug Administration; United States: Fred Hutchinson Cancer Research Center IRB |
Thoracic Neoplasms Anticarcinogenic Agents Beta Carotene Antioxidants Trace Elements Respiratory Tract Diseases Retinol palmitate |
Lung Neoplasms Lung Diseases Vitamin A Vitamins Micronutrients Carotenoids |
Anticarcinogenic Agents Thoracic Neoplasms Respiratory Tract Neoplasms Beta Carotene Antioxidants Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs Protective Agents Pharmacologic Actions |
Neoplasms Neoplasms by Site Respiratory Tract Diseases Retinol palmitate Lung Neoplasms Therapeutic Uses Vitamins Lung Diseases Vitamin A Micronutrients Carotenoids |