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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Jonsson Comprehensive Cancer Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01912820
First received: July 29, 2013
Last updated: May 27, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
Adenocarcinoma of the Prostate
Recurrent Prostate Cancer
Stage I Prostate Cancer
Stage IIA Prostate Cancer
Stage IIB Prostate Cancer
Stage III Prostate Cancer
Stage IV Prostate Cancer
Dietary Supplement: green tea extract
Drug: quercetin
Other: placebo
Procedure: therapeutic conventional surgery
Other: laboratory biomarker analysis
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Jonsson Comprehensive Cancer Center:

Primary Outcome Measures:
  • Green tea polyphenols, quercetin and their metabolite concentration in blood and prostate tissue [ Time Frame: On the day of surgery ] [ Designated as safety issue: No ]
    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:
  • Protein and gene expression of COMT in prostate tissue [ Time Frame: Day of surgery ] [ Designated as safety issue: No ]
  • Protein and gene expression of DNMT1 in prostate tissue [ Time Frame: Day of surgery ] [ Designated as safety issue: No ]
  • Protein and gene expression of MRP1 in prostate tissue [ Time Frame: Day of surgery ] [ Designated as safety issue: No ]
  • COMT activity in red blood cells [ Time Frame: Week 3 ] [ Designated as safety issue: No ]
  • Genotype of COMT (high [H]/H, low [L]/L or H/L) [ Time Frame: Week 3 ] [ Designated as safety issue: No ]
    Gene-association analyses will be conducted for COMT polymorphic variants within each intervention group using SAS Genetics, version 9.1


Estimated Enrollment: 30
Study Start Date: January 2014
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: green tea polyphenols
Drug: quercetin
Given PO
Other Name: 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 Name: green tea polyphenols
Other: placebo
Given PO
Other Name: PLCB
Procedure: therapeutic conventional surgery
Undergo prostatectomy
Other: laboratory biomarker analysis
Correlative studies

Detailed Description:

PRIMARY OBJECTIVES:

I. 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.

II. 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.

III. 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.

IV. 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.

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01912820

Locations
United States, California
Jonsson Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90095
Contact: Susanne Henning    310-825-9345    shenning@mednet.ucla.edu   
Principal Investigator: Susanne Henning         
Veterans Administration Los Angeles Healthcare System Recruiting
Los Angeles, California, United States, 90073
Contact: William Aronson       waronson@ucla.edu   
Principal Investigator: William Aronson         
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
Principal Investigator: Susanne Henning Jonsson Comprehensive Cancer Center
  More Information

No publications provided

Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01912820     History of Changes
Other Study ID Numbers: 12-000886, NCI-2013-01153, P30CA016042, R03CA171583
Study First Received: July 29, 2013
Last Updated: May 27, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Prostatic Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Quercetin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 28, 2014