Lung CancerPhase 4CARETNCT00712647
Carotene and Retinol Efficacy Trial
A Phase 4 study testing Beta Carotene and Retinol in people with Lung Cancer, run by Fred Hutchinson Cancer Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Beta Carotene and Retinol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18,314 participants
- Where
- No sites listed yet
- Study dates
- May 1985to Jun 2005
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
About this study
Official title: Caret and Retinol Efficacy Trial: The Caret Coordinating Center
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.
- Conditions
- Lung Cancer
- Being tested
- Beta Carotene and Retinol, Placebo
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beta Carotene and RetinolDrug
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
PlaceboOther
Two placebos, one each/day
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Asbestos-exposed participants and heavy smokers Receives: Drug: Beta Carotene and Retinol |
| 2 | Placebo comparator | Asbestos-exposed participants and heavy smokers Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung Cancer Incidence
Measured: bi-annual
Secondary outcomes (1)
Other cancers
Measured: bi-annual
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2008 (estimated)
- Study startMay 1985
- Primary completionDec 2004
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 18,314 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Gary E Goodman, MD, Principal investigator, Fred Hutchinson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00712647
- Sponsor's protocol ID
- FHCRC IR-4239A
- Other IDs
- U01CA063673, 4239A
- Acronym
- CARET
- Status last verified
- Sep 2012
- First submitted
- 8 Jul 2008
- Last updated
- 26 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caret and Retinol Efficacy Trial: The Caret Coordinating Center
- ClinicalTrials.gov ID
- NCT00712647
- Acronym / sponsor ID
- CARET / FHCRC IR-4239A
- Conditions
- Lung Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18,314 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 1985
- Primary completion
- Dec 2004 (actual)
- Study completion
- Jun 2005 (actual)
- First posted
- 10 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Beta Carotene and RetinolAsbestos-exposed participants and heavy smokers |
| 2 | Placebo comparator | Other: PlaceboAsbestos-exposed participants and heavy smokers |
Who may qualify
- Ages
- 45 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Asbestos-exposed men who were:
- Heavy Smokers, men and women:
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Beta Carotene and RetinolPilot 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 | Drug | 1 |
| PlaceboTwo placebos, one each/day | Other | 2 |
Primary outcome
Lung Cancer Incidence
Time frame: bi-annual
1 secondary outcome
Other cancers
Time frame: bi-annual
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gary E Goodman, MD principal investigator
Fred Hutchinson Cancer Center
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Beta Carotene and Retinol in people with Lung Cancer, run by Fred Hutchinson Cancer Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung Cancer Incidence (time frame: bi-annual). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2012.