Correlative Analysis of the Genomics of Vitamin D and Omega-3 Fatty Acid Intake in Prostate Cancer

NCT03290417 | Completed

• 1 other identifier: CASE3816
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to see if eating vitamin D, omega 3 and turmeric (curcumin) slows the growth of prostate cancer in men on active surveillance.

Conditions

Prostate Cancer

Keywords

Active Surveillance; Vitamin D; Omega-3 Fatty Acid; tumeric curcumin

Outcome Measures

Primary Outcomes (2)

• gene expression of very low and low risk prostate cancer patients on Active Surveillance

  The primary objective is to investigate the influence of vitamin D, omega-3 fatty acids, and turmeric curcumin intake on the genomic landscape of NCCN very low and low risk patients managed with Active Surveillance. This will be measured by using genomic signatures in Decipher GRID and using the mixed effect linear model that tests for the interaction of treatment arm and time

  Up to 6 months

• gene expression of very low and low risk prostate cancer patients on Active Surveillance

  The primary objective is to investigate the influence of vitamin D, omega-3 fatty acids, and turmeric curcumin intake on the genomic landscape of NCCN very low and low risk patients managed with Active Surveillance. This will be measured by using genomic signatures in Decipher GRID and using the mixed effect linear model that tests for the interaction of treatment arm and time

  Up to 12 months

Secondary Outcomes (2)

• Active Surveillance Failure

  Up to 12 months

• Time to Active Surveillance Failure

  Up to 12 months

Study Arms (2)

Unmodified Diet

NO INTERVENTION

Patients are under active surveillance with no modification to their diet, as is standard of care for low risk prostate cancer

Diet modification

EXPERIMENTAL

Patients receive Vitamin D, Omega-3 and turmeric curcumin as dietary supplements

Dietary Supplement: Vitamin D; Dietary Supplement: Omega-3; Dietary Supplement: Turmeric

Interventions

Vitamin D DIETARY_SUPPLEMENT

5000 IU/cap; One cap by mouth daily

Also known as: Vitamin D3

Diet modification

Omega-3 DIETARY_SUPPLEMENT

720 mg/cap; one capsule by mouth 3 times per day

Also known as: Omegagenics

Diet modification

Turmeric DIETARY_SUPPLEMENT

250mg/cap; two capsules by mouth 4 times per day

Also known as: Turmeric curcumin

Diet modification

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must have the diagnosis of prostate cancer and be on active surveillance. For the purpose of this study, Active surveillance implies prostate-specific antigen (PSA)\<10 ng/mL, biopsy Gleason sum \</=6 with no pattern 4 or 5, cancer involvement of \<33% of biopsy cores, and clinical stage T1/T2a tumor.
• 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.

You may not qualify if:

• Subjects receiving any treatment other than AS for prostate cancer.
• Subjects not followed by the Cleveland Clinic.
• Subjects unable to adhere to the dietary modification outlined in the protocol.

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

Cleveland Clinic, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Vitamin D; Cholecalciferol; Docosahexaenoic Acids; Curcumin

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholestenes; Cholestanes; Sterols; Membrane Lipids; Lipids; Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils; Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Officials

• David Levy, MD

  Cleveland Clinic, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel groups, one with a control diet, the other with a modified diet

Study Record Dates

• First Submitted: September 19, 2017
• First Posted: September 21, 2017
• Study Start: September 7, 2017
• Primary Completion: June 20, 2019
• Study Completion: December 20, 2019
• Last Updated: February 18, 2020

Record last verified: 2020-02

Locations

US (1)