N/A
Completed N=113
Green Tea, Black Tea, or Water in Treating Patients With Prostate Cancer Undergoing Surgery
Source: ClinicalTrials.gov NCT00685516 ↗Enrolled (actual)
113
Serious AEs
0.0%
Results posted
Jun 2016
Primary outcomePrimary: 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. — 2.48; 2.3; 4.38; 6.96 percent positive of total cells
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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. |
2.48; 2.3; 4.38; 6.96; 6.7; 6.57 | — |
| SECONDARY Concentration of Tea Polyphenols, Their Metabolites, and Colonic Metabolites in Prostate Tissue |
42.1; 0; 0; 17.8; 0; 0 | — |
| SECONDARY Concentration of Tea Polyphenols and Methyl-metabolites in Urine After the Consumption of Green Tea (GT) and Black Tea (BT). |
9.2; 0; .4; 4.8; 0; .3 | — |
| SECONDARY Prostate Specific Antigen (PSA) After the Consumption of Green Tea (GT) and Black Tea (BT). |
8.4; 10.0; 9.6 | — |
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
Data sourced from ClinicalTrials.gov (NCT00685516). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.