Trial Outcomes & Findings for Green Tea, Black Tea, or Water in Treating Patients With Prostate Cancer Undergoing Surgery (NCT NCT00685516)
NCT ID: NCT00685516
Last Updated: 2020-12-31
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
113 participants
Primary outcome timeframe
6 weeks
Results posted on
2020-12-31
Participant Flow
Participant milestones
| Measure |
Arm I - Green Tea
Patients receive 6 cups of green tea daily for 2-8 weeks in the absence of unacceptable toxicity.
green tea: 6 cups of green tea daily for 2-8 weeks
|
Arm II - Water
Patients receive 6 cups of water daily for 2-8 weeks in the absence of unacceptable toxicity.
placebo: 6 cups of water daily for 2-8 weeks
|
Arm III - Decaffeinated Black Tea
Patients receive 6 cups of decaffeinated black tea daily for 2-8 weeks in the absence of unacceptable toxicity.
decaffeinated black tea: 6 cups of decaffeinated black tea daily for 2-8 weeks
|
|---|---|---|---|
|
Overall Study
STARTED
|
42
|
38
|
33
|
|
Overall Study
COMPLETED
|
34
|
33
|
26
|
|
Overall Study
NOT COMPLETED
|
8
|
5
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Green Tea, Black Tea, or Water in Treating Patients With Prostate Cancer Undergoing Surgery
Baseline characteristics by cohort
| Measure |
Arm I - Green Tea
n=34 Participants
Patients receive 6 cups of green tea daily for 2-8 weeks in the absence of unacceptable toxicity.
green tea: 6 cups of green tea daily for 2-8 weeks
|
Arm II - Water
n=33 Participants
Patients receive 6 cups of water daily for 2-8 weeks in the absence of unacceptable toxicity.
placebo: 6 cups of water daily for 2-8 weeks
|
Arm III - Decaffeinated Black Tea
n=26 Participants
Patients receive 6 cups of decaffeinated black tea daily for 2-8 weeks in the absence of unacceptable toxicity.
decaffeinated black tea: 6 cups of decaffeinated black tea daily for 2-8 weeks
|
Total
n=93 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
62.1 years
STANDARD_DEVIATION 6.9 • n=5 Participants
|
61.8 years
STANDARD_DEVIATION 6.2 • n=7 Participants
|
61.4 years
STANDARD_DEVIATION 7.4 • n=5 Participants
|
61.8 years
STANDARD_DEVIATION 6.8 • n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
93 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
63 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
34 participants
n=5 Participants
|
33 participants
n=7 Participants
|
26 participants
n=5 Participants
|
93 participants
n=4 Participants
|
|
Weight (KG)
|
85.7 kg
STANDARD_DEVIATION 12.2 • n=5 Participants
|
86.6 kg
STANDARD_DEVIATION 14.3 • n=7 Participants
|
89.9 kg
STANDARD_DEVIATION 13.4 • n=5 Participants
|
87.6 kg
STANDARD_DEVIATION 14 • n=4 Participants
|
|
Height (cm)
|
176 cm
STANDARD_DEVIATION 21 • n=5 Participants
|
175 cm
STANDARD_DEVIATION 22 • n=7 Participants
|
175 cm
STANDARD_DEVIATION 22 • n=5 Participants
|
175.3 cm
STANDARD_DEVIATION 22 • n=4 Participants
|
|
BMI (kg/m^2)
|
27.2 kg/m^2
STANDARD_DEVIATION 3.8 • n=5 Participants
|
27.4 kg/m^2
STANDARD_DEVIATION 4.9 • n=7 Participants
|
27.4 kg/m^2
STANDARD_DEVIATION 3.6 • n=5 Participants
|
27.3 kg/m^2
STANDARD_DEVIATION 4 • n=4 Participants
|
|
Biopsy Gleason Score (percent)
6
|
18 participants
n=5 Participants
|
12 participants
n=7 Participants
|
11 participants
n=5 Participants
|
41 participants
n=4 Participants
|
|
Biopsy Gleason Score (percent)
7 (3+4)
|
9 participants
n=5 Participants
|
15 participants
n=7 Participants
|
9 participants
n=5 Participants
|
33 participants
n=4 Participants
|
|
Biopsy Gleason Score (percent)
7 (4+3)
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
9 participants
n=4 Participants
|
|
Biopsy Gleason Score (percent)
greater than or equal to 8
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
10 participants
n=4 Participants
|
|
Serum prostate-specific antigen (PSA)
|
9.6 ng/mL
STANDARD_DEVIATION 5.2 • n=5 Participants
|
9.9 ng/mL
STANDARD_DEVIATION 8.5 • n=7 Participants
|
9.2 ng/mL
STANDARD_DEVIATION 4.3 • n=5 Participants
|
9.6 ng/mL
STANDARD_DEVIATION 6 • n=4 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: subjects that completed study
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.
Outcome measures
| Measure |
Arm I - Green Tea
n=34 Participants
Patients receive 6 cups of green tea daily for 2-8 weeks in the absence of unacceptable toxicity.
|
Arm II - Water
n=33 Participants
Placebo:patients receive 6 cups of water daily for 2-8 weeks in the absence of unacceptable toxicity.
|
Arm III - Decaffeinated Black Tea
n=26 Participants
Patients receive 6 cups of decaffeinated black tea daily for 2-8 weeks in the absence of unacceptable toxicity.
|
|---|---|---|---|
|
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.
Staining proliferation (Ki67)
|
2.48 percent positive of total cells
Standard Deviation 1.83
|
2.3 percent positive of total cells
Standard Deviation 1.55
|
4.38 percent positive of total cells
Standard Deviation 4.1
|
|
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.
Staining apoptosis Tunel
|
6.96 percent positive of total cells
Standard Deviation 8.56
|
6.7 percent positive of total cells
Standard Deviation 9.1
|
6.57 percent positive of total cells
Standard Deviation 8.85
|
|
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.
Staining oxidative DNA Damage 8OHdG
|
5.5 percent positive of total cells
Standard Deviation 7.4
|
7.27 percent positive of total cells
Standard Deviation 10.68
|
11.23 percent positive of total cells
Standard Deviation 12.01
|
|
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.
Staining Proliferation Bax
|
37.4 percent positive of total cells
Standard Deviation 11
|
37.06 percent positive of total cells
Standard Deviation 8.71
|
37.35 percent positive of total cells
Standard Deviation 7.58
|
|
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.
Staining Proliferation Bcl-2
|
2.92 percent positive of total cells
Standard Deviation 2.97
|
5.21 percent positive of total cells
Standard Deviation 6.91
|
6.48 percent positive of total cells
Standard Deviation 6.25
|
|
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.
NFKB cytoplasmic staining
|
21.23 percent positive of total cells
Standard Deviation 20.46
|
22.3 percent positive of total cells
Standard Deviation 14.62
|
19.21 percent positive of total cells
Standard Deviation 14.63
|
|
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.
NFkB nuclear staining
|
1.46 percent positive of total cells
Standard Deviation 1.79
|
5.13 percent positive of total cells
Standard Deviation 6.37
|
4.58 percent positive of total cells
Standard Deviation 6.61
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: Concentration of tea polyphenols and methyl-metabolites in prostate tissue after the consumption of GT and BT. No polyphenols were found after water consumption. (-)-epigallocatechin-3-gallate (EGCG), (-)-epicatechin-3-gallate (ECG), (-)-epigallocatechin (EGC) , (-)-epicatechin (EC), 4'-O-methylEGC (4'-MeEGC), 4"-O-methylEGCG (4"-OmethylEGCG).
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.
Outcome measures
| Measure |
Arm I - Green Tea
n=34 Participants
Patients receive 6 cups of green tea daily for 2-8 weeks in the absence of unacceptable toxicity.
|
Arm II - Water
n=33 Participants
Placebo:patients receive 6 cups of water daily for 2-8 weeks in the absence of unacceptable toxicity.
|
Arm III - Decaffeinated Black Tea
n=26 Participants
Patients receive 6 cups of decaffeinated black tea daily for 2-8 weeks in the absence of unacceptable toxicity.
|
|---|---|---|---|
|
Concentration of Tea Polyphenols, Their Metabolites, and Colonic Metabolites in Prostate Tissue
EGCG
|
42.1 (pmol/g tissue)
Standard Deviation 32.4
|
0 (pmol/g tissue)
Standard Deviation 0
|
0 (pmol/g tissue)
Standard Deviation 0
|
|
Concentration of Tea Polyphenols, Their Metabolites, and Colonic Metabolites in Prostate Tissue
ECG
|
17.8 (pmol/g tissue)
Standard Deviation 10.1
|
0 (pmol/g tissue)
Standard Deviation 0
|
0 (pmol/g tissue)
Standard Deviation 0
|
|
Concentration of Tea Polyphenols, Their Metabolites, and Colonic Metabolites in Prostate Tissue
4" MeEGCG
|
38.9 (pmol/g tissue)
Standard Deviation 19.5
|
0 (pmol/g tissue)
Standard Deviation 0
|
0 (pmol/g tissue)
Standard Deviation 0
|
|
Concentration of Tea Polyphenols, Their Metabolites, and Colonic Metabolites in Prostate Tissue
Theaflavin
|
0 (pmol/g tissue)
Standard Deviation 0
|
0 (pmol/g tissue)
Standard Deviation 0
|
0 (pmol/g tissue)
Standard Deviation 0
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: Urine concentration of (-)-epigallocatechin-3-gallate (EGCG), (-)-epicatechin-3-gallate (ECG), (-)-epigallocatechin (EGC) , (-)-epicatechin (EC), 4'-O-methylEGC (4'-MeEGC), 4"-O-methylEGCG (4"-OmethylEGCG).
Concentration of tea polyphenols and methyl-metabolites in urine after the consumption of GT and BT. No polyphenols were found after water consumption
Outcome measures
| Measure |
Arm I - Green Tea
n=34 Participants
Patients receive 6 cups of green tea daily for 2-8 weeks in the absence of unacceptable toxicity.
|
Arm II - Water
n=33 Participants
Placebo:patients receive 6 cups of water daily for 2-8 weeks in the absence of unacceptable toxicity.
|
Arm III - Decaffeinated Black Tea
n=26 Participants
Patients receive 6 cups of decaffeinated black tea daily for 2-8 weeks in the absence of unacceptable toxicity.
|
|---|---|---|---|
|
Concentration of Tea Polyphenols and Methyl-metabolites in Urine After the Consumption of Green Tea (GT) and Black Tea (BT).
EGC
|
9.2 umol/g creatinine
Standard Deviation 16
|
0 umol/g creatinine
Standard Deviation 0
|
.4 umol/g creatinine
Standard Deviation .4
|
|
Concentration of Tea Polyphenols and Methyl-metabolites in Urine After the Consumption of Green Tea (GT) and Black Tea (BT).
EC
|
4.8 umol/g creatinine
Standard Deviation 6.1
|
0 umol/g creatinine
Standard Deviation 0
|
.3 umol/g creatinine
Standard Deviation .3
|
|
Concentration of Tea Polyphenols and Methyl-metabolites in Urine After the Consumption of Green Tea (GT) and Black Tea (BT).
4'-MeEGC
|
8.0 umol/g creatinine
Standard Deviation 18
|
0 umol/g creatinine
Standard Deviation 0
|
.2 umol/g creatinine
Standard Deviation .3
|
|
Concentration of Tea Polyphenols and Methyl-metabolites in Urine After the Consumption of Green Tea (GT) and Black Tea (BT).
Theaflavins
|
0 umol/g creatinine
Standard Deviation 0
|
0 umol/g creatinine
Standard Deviation 0
|
0 umol/g creatinine
Standard Deviation 0
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: Pre and post blood samples unavailable for: 4 participants in Arm I (GT group), 3 participants in Arm II (control/water group) and 3 participants in Arm III (BT group).
Outcome measures
| Measure |
Arm I - Green Tea
n=30 Participants
Patients receive 6 cups of green tea daily for 2-8 weeks in the absence of unacceptable toxicity.
|
Arm II - Water
n=30 Participants
Placebo:patients receive 6 cups of water daily for 2-8 weeks in the absence of unacceptable toxicity.
|
Arm III - Decaffeinated Black Tea
n=23 Participants
Patients receive 6 cups of decaffeinated black tea daily for 2-8 weeks in the absence of unacceptable toxicity.
|
|---|---|---|---|
|
Prostate Specific Antigen (PSA) After the Consumption of Green Tea (GT) and Black Tea (BT).
|
8.4 ng/mL
Standard Deviation 4.3
|
10.0 ng/mL
Standard Deviation 9.0
|
9.6 ng/mL
Standard Deviation 6.0
|
Adverse Events
Arm I - Green Tea
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm II - Water
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm III - Decaffeinated Black Tea
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place