Effect of Quercetin on Green Tea Polyphenol Uptake in Prostate Tissue From Patients With Prostate Cancer Undergoing Surgery
NCT ID: NCT01912820
Last Updated: 2021-06-23
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
PHASE1
32 participants
INTERVENTIONAL
2014-01-01
2021-06-10
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Arm I (quercetin, green tea extract)
Patients receive GT extract PO BID and quercetin PO BID for 3-6 weeks before undergoing prostatectomy.
green tea extract
Given PO
quercetin
Given PO
therapeutic conventional surgery
Undergo prostatectomy
laboratory biomarker analysis
Correlative studies
Arm II (GT extract, placebo)
Patients receive GT extract PO BID and placebo PO BID for 3-6 weeks before undergoing prostatectomy.
green tea extract
Given PO
placebo
Given PO
therapeutic conventional surgery
Undergo prostatectomy
laboratory biomarker analysis
Correlative studies
Interventions
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green tea extract
Given PO
quercetin
Given PO
placebo
Given PO
therapeutic conventional surgery
Undergo prostatectomy
laboratory biomarker analysis
Correlative studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
75 Years
MALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Jonsson Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Susanne Henning, MD
Role: PRINCIPAL_INVESTIGATOR
Jonsson Comprehensive Cancer Center
Locations
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Veterans Administration Los Angeles Healthcare System
Los Angeles, California, United States
Jonsson Comprehensive Cancer Center
Los Angeles, California, United States
Countries
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Other Identifiers
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NCI-2013-01153
Identifier Type: REGISTRY
Identifier Source: secondary_id
12-000886
Identifier Type: -
Identifier Source: org_study_id
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