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Caret and Retinol Efficacy Trial: The Caret Coordinating Center


Phase 4
45 Years
69 Years
Not Enrolling
Both
Lung Cancer

Thank you

Trial Information

Caret and Retinol Efficacy Trial: The Caret Coordinating Center


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

Lung Cancer Incidence

Outcome Time Frame:

bi-annual

Safety Issue:

Yes

Principal Investigator

Gary E Goodman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fred Hutchinson Cancer Research Center

Authority:

United States: Food and Drug Administration

Study ID:

FHCRC IR-4239A

NCT ID:

NCT00712647

Start Date:

May 1985

Completion Date:

June 2005

Related Keywords:

  • Lung Cancer
  • Lung Neoplasms

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