Correlative Analysis of the Genomics of Vitamin D and Omega-3 Fatty Acid Intake in Prostate Cancer
NCT ID: NCT03290417
Last Updated: 2020-02-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
37 participants
INTERVENTIONAL
2017-09-07
2019-12-20
Brief Summary
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Detailed Description
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The secondary objective is to evaluate prostate cancer aggressiveness pre and post intervention by looking at genes and gene signatures associated with vitamin D and omega-3 fatty acids pathways. Prognostic performance of GRID gene signatures will be evaluated using Active Surveillance 'Failure' (deferred treatment) as an additional endpoint.
The exploratory objective is to be able to use predictive genes and/or genomic signatures to assess benefit from vitamin D, omega-3 fatty acid and turmeric curcumin intake. This will only be possible once sufficient patient follow up is available.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Unmodified Diet
Patients are under active surveillance with no modification to their diet, as is standard of care for low risk prostate cancer
No interventions assigned to this group
Diet modification
Patients receive Vitamin D, Omega-3 and turmeric curcumin as dietary supplements
Vitamin D
5000 IU/cap; One cap by mouth daily
Omega-3
720 mg/cap; one capsule by mouth 3 times per day
Turmeric
250mg/cap; two capsules by mouth 4 times per day
Interventions
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Vitamin D
5000 IU/cap; One cap by mouth daily
Omega-3
720 mg/cap; one capsule by mouth 3 times per day
Turmeric
250mg/cap; two capsules by mouth 4 times per day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects must be followed at the Cleveland Clinic for active surveillance.
* Subjects must be willing to adhere to the dietary modification outlined in the protocol.
* Subjects must be willing to have prostate biopsies at the baseline, and six months after enrollment into the protocol
* Subjects must have the ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria
* Subjects not followed by the Cleveland Clinic.
* Subjects unable to adhere to the dietary modification outlined in the protocol.
MALE
No
Sponsors
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Case Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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David Levy, MD
Role: PRINCIPAL_INVESTIGATOR
Cleveland Clinic, Case Comprehensive Cancer Center
Locations
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Cleveland Clinic, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Countries
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Other Identifiers
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CASE3816
Identifier Type: -
Identifier Source: org_study_id
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