Green Tea, Black Tea, or Water in Treating Patients With Prostate Cancer Undergoing Surgery
Effects of Brewed Green and Black Tea on Inflammation, Apoptosis and Oxidation in Men With Prostate Cancer
4 other identifiers
interventional
113
1 country
2
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 cancer. PURPOSE: This randomized phase II trial is studying green tea to see how well it works compared with black tea and water in treating patients with prostate cancer undergoing surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable prostate-cancer
Started Sep 2007
Longer than P75 for not_applicable prostate-cancer
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
May 22, 2008
CompletedFirst Posted
Study publicly available on registry
May 28, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 12, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedResults Posted
Study results publicly available
June 6, 2016
CompletedDecember 31, 2020
September 1, 2020
4.4 years
May 22, 2008
February 18, 2016
December 8, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Effect of Green Tea (GT) and Black Tea (BT) Consumption on Percentage of Cells With Positive Staining for Apoptosis, Proliferation, Oxidation, and Inflammation in Malignant Radical Prostatectomy Tissue Compared to Water Control Using Immunohistochemistry.
To determine the effect of Green Tea and Black Tea consumption on Prostate cancer tissue by examining programmed cell death, cell proliferation, cell oxidation, and cellular inflammation in that malignant radical prostatectomy tissue compared to water control using immunohistochemistry.
6 weeks
Secondary Outcomes (3)
Concentration of Tea Polyphenols, Their Metabolites, and Colonic Metabolites in Prostate Tissue
6 weeks
Concentration of Tea Polyphenols and Methyl-metabolites in Urine After the Consumption of Green Tea (GT) and Black Tea (BT).
6 weeks
Prostate Specific Antigen (PSA) After the Consumption of Green Tea (GT) and Black Tea (BT).
6 weeks
Study Arms (3)
Arm I - Green Tea
ACTIVE COMPARATORPatients receive 6 cups of green tea daily for 2-8 weeks in the absence of unacceptable toxicity.
Arm II - Water
PLACEBO COMPARATORPatients receive 6 cups of water daily for 2-8 weeks in the absence of unacceptable toxicity.
Arm III - Decaffeinated black tea
ACTIVE COMPARATORPatients receive 6 cups of decaffeinated black tea daily for 2-8 weeks in the absence of unacceptable toxicity.
Interventions
6 cups of decaffeinated black tea daily for 2-8 weeks
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Veterans Affairs Medical Center - West Los Angeles
Los Angeles, California, 90073, United States
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, 90095-1781, United States
Related Publications (1)
Henning SM, Wang P, Said JW, Huang M, Grogan T, Elashoff D, Carpenter CL, Heber D, Aronson WJ. Randomized clinical trial of brewed green and black tea in men with prostate cancer prior to prostatectomy. Prostate. 2015 Apr 1;75(5):550-9. doi: 10.1002/pros.22943. Epub 2014 Dec 24.
PMID: 25545744RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Susanne Henning, Ph.D., Principal Investigator
- Organization
- UCLA
Study Officials
- PRINCIPAL INVESTIGATOR
Susanne M. Henning, PhD, RD
Jonsson Comprehensive Cancer Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 22, 2008
First Posted
May 28, 2008
Study Start
September 1, 2007
Primary Completion
January 12, 2012
Study Completion
April 1, 2015
Last Updated
December 31, 2020
Results First Posted
June 6, 2016
Record last verified: 2020-09