Clinical trial NCT00685516: Green Tea, Black Tea, or Water in Treating Patients With Prostate Cancer Undergoing Surgery
Official title: Effects of Brewed Green and Black Tea on Inflammation, Apoptosis and Oxidation in Men With Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: adenocarcinoma of the prostate
recurrent prostate cancer
stage I prostate cancer
stage II prostate cancer
stage III prostate cancer
stage IV prostate cancer
Lead sponsor: Jonsson Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2008-05-28
Enrollment: 113
Sex: MALE
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: 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.
timeFrame: 6 weeks
Secondary outcomes:
measure: Concentration of Tea Polyphenols, Their Metabolites, and Colonic Metabolites in Prostate Tissue
timeFrame: 6 weeks
measure: Concentration of Tea Polyphenols and Methyl-metabolites in Urine After the Consumption of Green Tea (GT) and Black Tea (BT).
timeFrame: 6 weeks
measure: Prostate Specific Antigen (PSA) After the Consumption of Green Tea (GT) and Black Tea (BT).
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Veterans Affairs Medical Center - West Los Angeles
state: California
city: Los Angeles
country: United States
facility: Jonsson Comprehensive Cancer Center at UCLA
state: California
Study officials:
affiliation: Jonsson Comprehensive Cancer Center
name: Susanne M. Henning, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.