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NCT00685516

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

Completed NA Results posted Last updated 31 December 2020
What this trial tests

NA trial testing green tea in Prostate Cancer in 113 participants. Completed in 1 April 2015.

Timeline
1 September 2007
Primary endpoint
12 January 2012
1 April 2015

Quick facts

Lead sponsorJonsson Comprehensive Cancer Center
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment113
Start date1 September 2007
Primary completion12 January 2012
Estimated completion1 April 2015
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Jonsson Comprehensive Cancer Center — full company profile →

Who can join

Adults 40 to 75, male only, with Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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. Primary · 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.

Staining proliferation (Ki67)
GroupValue95% CI
Arm I - Green Tea2.48± 1.83
Arm II - Water2.3± 1.55
Arm III - Decaffeinated Black Tea4.38± 4.1
Staining apoptosis Tunel
GroupValue95% CI
Arm I - Green Tea6.96± 8.56
Arm II - Water6.7± 9.1
Arm III - Decaffeinated Black Tea6.57± 8.85
Staining oxidative DNA Damage 8OHdG
GroupValue95% CI
Arm I - Green Tea5.5± 7.4
Arm II - Water7.27± 10.68
Arm III - Decaffeinated Black Tea11.23± 12.01
Staining Proliferation Bax
GroupValue95% CI
Arm I - Green Tea37.4± 11
Arm II - Water37.06± 8.71
Arm III - Decaffeinated Black Tea37.35± 7.58
Staining Proliferation Bcl-2
GroupValue95% CI
Arm I - Green Tea2.92± 2.97
Arm II - Water5.21± 6.91
Arm III - Decaffeinated Black Tea6.48± 6.25
NFKB cytoplasmic staining
GroupValue95% CI
Arm I - Green Tea21.23± 20.46
Arm II - Water22.3± 14.62
Arm III - Decaffeinated Black Tea19.21± 14.63
NFkB nuclear staining
GroupValue95% CI
Arm I - Green Tea1.46± 1.79
Arm II - Water5.13± 6.37
Arm III - Decaffeinated Black Tea4.58± 6.61
Concentration of Tea Polyphenols, Their Metabolites, and Colonic Metabolites in Prostate Tissue Secondary · 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.

EGCG
GroupValue95% CI
Arm I - Green Tea42.1± 32.4
Arm II - Water0± 0
Arm III - Decaffeinated Black Tea0± 0
ECG
GroupValue95% CI
Arm I - Green Tea17.8± 10.1
Arm II - Water0± 0
Arm III - Decaffeinated Black Tea0± 0
4" MeEGCG
GroupValue95% CI
Arm I - Green Tea38.9± 19.5
Arm II - Water0± 0
Arm III - Decaffeinated Black Tea0± 0
Theaflavin
GroupValue95% CI
Arm I - Green Tea0± 0
Arm II - Water0± 0
Arm III - Decaffeinated Black Tea0± 0
Concentration of Tea Polyphenols and Methyl-metabolites in Urine After the Consumption of Green Tea (GT) and Black Tea (BT). Secondary · 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

EGC
GroupValue95% CI
Arm I - Green Tea9.2± 16
Arm II - Water0± 0
Arm III - Decaffeinated Black Tea.4± .4
EC
GroupValue95% CI
Arm I - Green Tea4.8± 6.1
Arm II - Water0± 0
Arm III - Decaffeinated Black Tea.3± .3
4'-MeEGC
GroupValue95% CI
Arm I - Green Tea8.0± 18
Arm II - Water0± 0
Arm III - Decaffeinated Black Tea.2± .3
Theaflavins
GroupValue95% CI
Arm I - Green Tea0± 0
Arm II - Water0± 0
Arm III - Decaffeinated Black Tea0± 0
Prostate Specific Antigen (PSA) After the Consumption of Green Tea (GT) and Black Tea (BT). Secondary · 6 weeks
GroupValue95% CI
Arm I - Green Tea8.4± 4.3
Arm II - Water10.0± 9.0
Arm III - Decaffeinated Black Tea9.6± 6.0

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Perspectives for cancer prevention with natural compounds.
    Amin AR, Kucuk O, Khuri FR, Shin DM. · · 2009 · cited 330× · PMID 19414669 · DOI 10.1200/jco.2008.20.6235
  2. Pharmacokinetic and chemoprevention studies on tea in humans.
    Chow HH, Hakim IA. · · 2011 · cited 91× · PMID 21624470 · DOI 10.1016/j.phrs.2011.05.007
  3. Effect of Tea Polyphenol Compounds on Anticancer Drugs in Terms of Anti-Tumor Activity, Toxicology, and Pharmacokinetics.
    Cao J, Han J, Xiao H, Qiao J, et al · · 2016 · cited 69× · PMID 27983622 · DOI 10.3390/nu8120762
  4. Randomized clinical trial of brewed green and black tea in men with prostate cancer prior to prostatectomy.
    Henning SM, Wang P, Said JW, Huang M, et al · · 2015 · cited 59× · PMID 25545744 · DOI 10.1002/pros.22943
  5. Complementary and alternative medicines in prostate cancer: from bench to bedside?
    Klempner SJ, Bubley G. · · 2012 · cited 28× · PMID 22618569 · DOI 10.1634/theoncologist.2012-0094
  6. Racial disparity in prostate cancer in the African American population with actionable ideas and novel immunotherapies.
    Dovey ZS, Nair SS, Chakravarty D, Tewari AK. · · 2021 · cited 18× · PMID 33599076 · DOI 10.1002/cnr2.1340
  7. Plant Extracts as Possible Agents for Sequela of Cancer Therapies and Cachexia.
    Lee J, Jeong MI, Kim HR, Park H, et al · · 2020 · cited 12× · PMID 32906727 · DOI 10.3390/antiox9090836
  8. Dietary Polyphenols against Oxidative Stress in Head and Neck Cancer: What's New, What's Next.
    Ballini A, Zhurakivska K, Troiano G, Lo Muzio L, et al · · 2024 · cited 7× · PMID 38169656 · DOI 10.7150/jca.90545

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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00685516.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing