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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00685516
First received: May 22, 2008
Last updated: April 27, 2016
Last verified: April 2016
  Purpose

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 Intervention Phase
Prostate Cancer
Dietary Supplement: green tea
Dietary Supplement: placebo
Dietary Supplement: decaffeinated black tea
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Brewed Green and Black Tea on Inflammation, Apoptosis and Oxidation in Men With Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Jonsson Comprehensive Cancer Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • Concentration of Tea Polyphenols, Their Metabolites, and Colonic Metabolites in Prostate Tissue [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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.

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

  • Prostate Specific Antigen (PSA) After the Consumption of Green Tea (GT) and Black Tea (BT). [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 113
Study Start Date: September 2007
Estimated Study Completion Date: August 2016
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00685516

Locations
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
Principal Investigator: Susanne M. Henning, PhD, RD Jonsson Comprehensive Cancer Center
  More Information

Publications:
Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00685516     History of Changes
Other Study ID Numbers: CDR0000596162  R01CA116242  P30CA016042  UCLA-061109702 
Study First Received: May 22, 2008
Results First Received: February 18, 2016
Last Updated: April 27, 2016
Health Authority: United States: Food and Drug Administration

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:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on July 21, 2016