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Effect of Quercetin on Green Tea Polyphenol Uptake in Prostate Tissue From Patients With Prostate Cancer Undergoing Surgery

Sponsor
Jonsson Comprehensive Cancer Center (Other)
Overall Status
Completed
CT.gov ID
NCT01912820
Collaborator
National Cancer Institute (NCI) (NIH)
32
Enrollment
2
Locations
2
Arms
89.3
Actual Duration (Months)
16
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This randomized pilot phase I trial will evaluate if quercetin enhances the uptake of green tea polyphenols in the prostate tissue of men taking green tea extract and undergoing radical prostatectomy. Side effects of green tea extract and quercetin in combination with green tea extract will also be evaluated. In preclinical studies, green tea polyphenols have anticancer and cancer preventative effects in a number of malignancies. Likewise, in preclinical studies quercetin was found to enhance the anticancer effects of green tea. This trial is designed to translate these findings forward in a short-term human intervention trial.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: green tea extract
  • Drug: quercetin
  • Other: placebo
  • Procedure: therapeutic conventional surgery
  • Other: laboratory biomarker analysis
 Phase 1

Detailed Description

PRIMARY OBJECTIVES:

  1. To investigate the prostate tissue concentration of epigallocatechin gallate (EGCG), epicatechin gallate (ECG) and quercetin and their methylated metabolites in men scheduled for prostatectomy and consuming green tea (GT)extract (N=15) or GTextract with quercetin (N=15) for 3 weeks prior to prostatectomy.

  2. To determine the concentration of EGCG, ECG, epigallocatechin (EGC), epicatechin (EC) and quercetin and the methylated metabolites in plasma collected before (T=0) and two hours (T=2) after the intake of the morning dose of GTextract and placebo or GTextract with quercetin during the third week of intervention.

  3. To determine the effect of GTextract/quercetin intervention on reducing the enzyme activity and protein and gene expression of catechol-O-methyltransferase (COMT) and deoxyribonucleic (DNA) (cytosine-5) methyltransferase 1 (DNMT1) as well as protein and gene expression of multidrug resistance transport protein 1 (MRP1) in prostate tissue collected in specific aim 1 and COMT activity in erythrocytes from blood collected at baseline and week 3.

  4. To determine the inter-individual variation in genotype of COMT in buffy coat DNA.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive GT extract orally (PO) twice daily (BID) and quercetin PO BID for 3-6 weeks before undergoing prostatectomy.

ARM II: Patients receive GT extract PO BID and placebo PO BID for 3-6 weeks before undergoing prostatectomy.

Study Design

Study Type:
Interventional
Actual Enrollment :
32 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Prevention
Official Title:
A Phase I Randomized, Double-Blind, Placebo-Controlled Two-Arm Study of Quercetin and Green Tea to Enhance the Bioavailability of Green Tea Polyphenols in Men Scheduled for Prostatectomy
Actual Study Start Date :
Jan 1, 2014
Actual Primary Completion Date :
Jan 31, 2016
Actual Study Completion Date :
Jun 10, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm I (quercetin, green tea extract)

Patients receive GT extract PO BID and quercetin PO BID for 3-6 weeks before undergoing prostatectomy.

Dietary Supplement: green tea extract
Given PO
Other Names:
  • green tea polyphenols

    • Drug: quercetin
    Given PO
    Other Names:
  • C.I. natural yellow 10

    • Procedure: therapeutic conventional surgery
    Undergo prostatectomy

    Other: laboratory biomarker analysis
    Correlative studies
    Placebo Comparator: Arm II (GT extract, placebo)

    Patients receive GT extract PO BID and placebo PO BID for 3-6 weeks before undergoing prostatectomy.

    Dietary Supplement: green tea extract
    Given PO
    Other Names:
  • green tea polyphenols

    • Other: placebo
    Given PO
    Other Names:
  • PLCB

    • Procedure: therapeutic conventional surgery
    Undergo prostatectomy

    Other: laboratory biomarker analysis
    Correlative studies

    Outcome Measures

    Primary Outcome Measures

    1. Green tea polyphenols, quercetin and their metabolite concentration in blood and prostate tissue [On the day of surgery]

      Means and standard deviation will be calculated and the statistical difference between treatment with GTextract + quercetin compared to GTextract + placebo will be determined using Student's t-test computed by one-way analysis of variance models.

    Secondary Outcome Measures

    1. Protein and gene expression of COMT in prostate tissue [Day of surgery]

    2. Protein and gene expression of DNMT1 in prostate tissue [Day of surgery]

    3. Protein and gene expression of MRP1 in prostate tissue [Day of surgery]

    4. COMT activity in red blood cells [Week 3]

    5. Genotype of COMT (high [H]/H, low [L]/L or H/L) [Week 3]

      Gene-association analyses will be conducted for COMT polymorphic variants within each intervention group using SAS Genetics, version 9.1

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 75 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Subjects consent to participate in the trial

    • The subject has a diagnosis of adenocarcinoma of the prostate

    • The subject is scheduled to undergo radical prostatectomy

    • The subject agrees to stop consuming tea or tea-containing products and quercetin supplements throughout the entire intervention period except for the green tea extract and quercetin provided during study intervention

    Exclusion Criteria:

    • History of hepatitis or liver dysfunction

    • Ongoing alcohol abuse

    • Significant medical or psychiatric conditions that would make the patient a poor protocol candidate

    • Prior sensitivity or allergic reaction to tea, tea products or tea and quercetin supplements

    • Allergies to multiple food items or nutritional supplements

    • Taking luteinizing hormone-releasing hormone (LHRH) agonists, androgen receptor blocking agents, finasteride, or has undergone bilateral orchiectomy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Veterans Administration Los Angeles Healthcare System Los Angeles California United States 90073
    2 Jonsson Comprehensive Cancer Center Los Angeles California United States 90095

    Sponsors and Collaborators

    • Jonsson Comprehensive Cancer Center
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Susanne Henning, MD, Jonsson Comprehensive Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jonsson Comprehensive Cancer Center
    ClinicalTrials.gov Identifier:
    NCT01912820
    Other Study ID Numbers:
    • 12-000886
    • NCI-2013-01153
    • R03CA171583
    First Posted:
    Jul 31, 2013
    Last Update Posted:
    Jun 23, 2021
    Last Verified:
    Jun 1, 2021
    Additional relevant MeSH terms:
    Prostatic Neoplasms
    Quercetin

    Study Results

    No Results Posted as of Jun 23, 2021