NCT00685516

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 113 (actual)
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: Male
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	green tea	6 cups of green tea daily for 2-8 weeks
DIETARY_SUPPLEMENT	placebo	6 cups of water daily for 2-8 weeks
DIETARY_SUPPLEMENT	decaffeinated black tea	6 cups of decaffeinated black tea daily for 2-8 weeks

Timeline

• Start date: 2007-09-01
• Primary completion: 2012-01-12
• Completion: 2015-04-01
• First posted: 2008-05-28
• Last updated: 2020-12-31
• Results posted: 2016-06-06

Locations

2 sites across 1 country: United States