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Green Tea, Black Tea, or Water in Treating Patients With Prostate Cancer Undergoing Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00685516
Recruitment Status : Completed
First Posted : May 28, 2008
Results First Posted : June 6, 2016
Last Update Posted : December 31, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

Study Description
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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.


Condition or disease Intervention/treatment Phase
Prostate Cancer Dietary Supplement: green tea Dietary Supplement: placebo Dietary Supplement: decaffeinated black tea Not Applicable

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 water control using immunohistochemistry.
  • to examine levels of tea polyphenols and methylated tea polyphenol metabolites in fresh frozen radical prostatectomy tissue and urine, urinary oxidative DNA damage (8OHdG) and serum prostate-specific antigen (PSA) levels.

OUTLINE: This is a multicenter, randomized study. Patients are randomized to 1 of 3 treatment arms.

  • Arm I: Patients receive 6 cups of green tea daily for 2-8 weeks in the absence of unacceptable toxicity.
  • Arm II: Patients receive 6 cups of water daily for 2-8 weeks in the absence of unacceptable toxicity.
  • Arm III: Patients receive 6 cups of decaffeinated black tea daily for 2-8 weeks in the absence of unacceptable toxicity.

Patients undergo radical prostatectomy.

Blood and urine samples, as well as tissue from diagnostic biopsy and radical prostatectomy specimens, are obtained for laboratory correlative studies. Samples are assessed by IHC, high-performance liquid chromatography, or mass spectrometry for changes in prostate tumor grade, stage, and margin status; concentrations of total and free tea polyphenols (i.e., EGCG, EC, EGC, ECG), theaflavins, and conjugated/colonic tea metabolites; biomarkers of prostate cancer development and progression (i.e., serum PSA, proliferation [i.e., Ki-67], apoptosis [i.e., TUNEL, Bax/Bcl-2 ratio], inflammation [i.e., NFkB]), and oxidative status (i.e., 8OhdG/dG ratio); and genotype and gene expression of metabolizing enzymes (i.e., COMT, UGT, and SULT). Serum samples are also assessed by ex vivo LNCaP cell culture assay for antiproliferative activity and by competitive chemiluminescent immunoassay for concentrations of PSA, IGF-1, IGFBP-3, testosterone, SHBG, and DHEA-sulfate.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 113 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Brewed Green and Black Tea on Inflammation, Apoptosis and Oxidation in Men With Prostate Cancer
Actual Study Start Date : September 1, 2007
Actual Primary Completion Date : January 12, 2012
Actual Study Completion Date : April 1, 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Arm I - Green Tea
Patients receive 6 cups of green tea daily for 2-8 weeks in the absence of unacceptable toxicity.
 Dietary Supplement: green tea
6 cups of green tea daily for 2-8 weeks
Placebo Comparator: Arm II - Water
Patients receive 6 cups of water daily for 2-8 weeks in the absence of unacceptable toxicity.
 Dietary Supplement: placebo
6 cups of water daily for 2-8 weeks
Active Comparator: Arm III - Decaffeinated black tea
Patients receive 6 cups of decaffeinated black tea daily for 2-8 weeks in the absence of unacceptable toxicity.
 Dietary Supplement: decaffeinated black tea
6 cups of decaffeinated black tea daily for 2-8 weeks


Outcome Measures
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Primary Outcome Measures :
  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. [ Time Frame: 6 weeks ]
    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.


Secondary Outcome Measures :
  1. Concentration of Tea Polyphenols, Their Metabolites, and Colonic Metabolites in Prostate Tissue [ Time Frame: 6 weeks ]
    Examine levels of tea polyphenols and methylated tea polyphenol metabolites in fresh frozen radical prostatectomy tissue and urine, urinary oxidative DNA damage (8OHdG) and serum prostate-specific antigen (PSA) levels.

  2. Concentration of Tea Polyphenols and Methyl-metabolites in Urine After the Consumption of Green Tea (GT) and Black Tea (BT). [ Time Frame: 6 weeks ]
    Concentration of tea polyphenols and methyl-metabolites in urine after the consumption of GT and BT. No polyphenols were found after water consumption

  3. Prostate Specific Antigen (PSA) After the Consumption of Green Tea (GT) and Black Tea (BT). [ Time Frame: 6 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 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 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00685516


Locations
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United States, California
Veterans Affairs Medical Center - West Los Angeles
Los Angeles, California, United States, 90073
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Susanne M. Henning, PhD, RD Jonsson Comprehensive Cancer Center
More Information
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Publications of Results:

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Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00685516    
Other Study ID Numbers: 10-001050
R01CA116242 ( U.S. NIH Grant/Contract )
UCLA-061109702 ( Other Identifier: UCLA )
CDR0000596162 ( Other Identifier: UCLA )
First Posted: May 28, 2008    Key Record Dates
Results First Posted: June 6, 2016
Last Update Posted: December 31, 2020
Last Verified: September 2020
Keywords provided by Jonsson Comprehensive Cancer Center:
adenocarcinoma of the prostate
recurrent prostate cancer
stage I prostate cancer
 stage II prostate cancer
stage III prostate cancer
stage IV prostate cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Prostatic Diseases