Effect of Quercetin on Green Tea Polyphenol Uptake in Prostate Tissue From Patients With Prostate Cancer Undergoing Surgery
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Prostate Cancer, Cancer, Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 40 - 75 |
| Updated: | 5/2/2018 |
| Start Date: | January 1, 2014 |
| End Date: | January 31, 2019 |
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
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.
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.
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.
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.
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
We found this trial at
2
sites
Los Angeles, California 90095
Principal Investigator: Susanne Henning
Phone: 310-825-9345
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Los Angeles, California 90073
Principal Investigator: William Aronson
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