Status:
COMPLETED
Green Tea, Black Tea, or Water in Treating Patients With Prostate Cancer Undergoing Surgery
Lead Sponsor:
Jonsson Comprehensive Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Prostate Cancer
Eligibility:
MALE
40-75 years
Phase:
NA
Brief Summary
RATIONALE: Green tea contains ingredients that may prevent or slow the growth of certain cancers. It is not yet known whether green tea is more effective than black tea or water in treating prostate c...
Detailed Description
OBJECTIVES: * to determine the effect of GT and BT consumption on apoptosis (TUNEL, ratio Bax:Bcl-2), proliferation, oxidation, and inflammation in malignant radical prostatectomy tissue compared to ...
Eligibility Criteria
Inclusion
- subject consents to participate in the trial.
- subject is 40-75 years of age and has a diagnosis of adenocarcinoma of the prostate.
- Scheduled to undergo radical prostatectomy.
- The subject agrees to stop consumption of tea or tea-containing products throughout the entire intervention period except for the tea provided during study intervention.
- The subject agrees to stop consumption of dietary or vitamin supplements (e.g., lycopene, Vitamin E, selenium, genistein) or herbal supplements (e.g., saw palmetto, PC-SPES)
Exclusion
- 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 supplements
- allergy or sensitivity to multiple food items or nutritional supplements
- concurrent luteinizing hormone-releasing hormone agonists, androgen receptor blocking agents, or finasteride
- prior bilateral orchiectomy
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
113 Patients enrolled
Trial Details
Trial ID
NCT00685516
Start Date
September 1 2007
End Date
April 1 2015
Last Update
December 31 2020
Active Locations (2)
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1
Veterans Affairs Medical Center - West Los Angeles
Los Angeles, California, United States, 90073
2
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781