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Green Tea Extract in Treating Patients With Nonmetastatic Bladder Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00666562
Recruitment Status : Completed
First Posted : April 25, 2008
Results First Posted : March 28, 2016
Last Update Posted : November 17, 2017
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Conditions Stage I Bladder Cancer
Stage II Bladder Cancer
Stage III Bladder Cancer
Interventions Dietary Supplement: Defined Green Tea Catechin Extract
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study
Drug: Placebo
Procedure: Therapeutic Conventional Surgery
Enrollment 31
Recruitment Details Participants were recruited during a 4 year period by staff at 5 participating institutions (both University hospitals and community clinics).
Pre-assignment Details  
Arm/Group Title Arm I (Placebo) Arm II (800mg Polyphenon E, Placebo) Arm III (1200mg Polyphenon E)
Hide Arm/Group Description

Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.

placebo: Given orally

pharmacological study: Correlative studies

laboratory biomarker analysis: Correlative studies

Patients receive four oral 800mg polyphenon E capsules and two oral placebo capsules once daily for 14-28 days in the absence of unacceptable toxicity.After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.

defined green tea catechin extract: Given orally

placebo: Given orally

pharmacological study: Correlative studies

laboratory biomarker analysis: Correlative studies

Patients receive six oral 1200mg polyphenon E capsules once daily for 14-28 days in the absence of unacceptable toxicity. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.

defined green tea catechin extract: Given orally

therapeutic conventional surgery: Undergo surgery

pharmacological study: Correlative studies

laboratory biomarker analysis: Correlative studies

Period Title: Overall Study
Started 11 10 10
Completed 11 8 10
Not Completed 0 2 0
Reason Not Completed
Withdrawal by Subject             0             1             0
Concomitant Medication             0             1             0
Arm/Group Title Arm I (Placebo) Arm II (800mg Polyphenon E, Placebo) Arm III (1200mg Polyphenon E) Total
Hide Arm/Group Description

Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.

placebo: Given orally

pharmacological study: Correlative studies

laboratory biomarker analysis: Correlative studies

Patients receive four oral 800mg polyphenon E capsules and two oral placebo capsules once daily for 14-28 days in the absence of unacceptable toxicity.After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.

defined green tea catechin extract: Given orally

placebo: Given orally

pharmacological study: Correlative studies

laboratory biomarker analysis: Correlative studies

Patients receive six oral 1200mg polyphenon E capsules once daily for 14-28 days in the absence of unacceptable toxicity. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.

defined green tea catechin extract: Given orally

therapeutic conventional surgery: Undergo surgery

pharmacological study: Correlative studies

laboratory biomarker analysis: Correlative studies

Total of all reporting groups
Overall Number of Baseline Participants 11 10 10 31
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 10 participants 10 participants 31 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
3
  27.3%
7
  70.0%
3
  30.0%
13
  41.9%
>=65 years
8
  72.7%
3
  30.0%
7
  70.0%
18
  58.1%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants 10 participants 10 participants 31 participants
70.00  (7.04) 65.20  (9.50) 66.20  (9.55) 67.23  (8.69)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 10 participants 10 participants 31 participants
Female
2
  18.2%
1
  10.0%
2
  20.0%
5
  16.1%
Male
9
  81.8%
9
  90.0%
8
  80.0%
26
  83.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 10 participants 10 participants 31 participants
Hispanic or Latino
3
  27.3%
2
  20.0%
2
  20.0%
7
  22.6%
Not Hispanic or Latino
8
  72.7%
8
  80.0%
8
  80.0%
24
  77.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 10 participants 10 participants 31 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
1
  10.0%
1
   3.2%
White
11
 100.0%
10
 100.0%
9
  90.0%
30
  96.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 11 participants 10 participants 10 participants 31 participants
11 10 10 31
1.Primary Outcome
Title Epigallocatechin Gallate (EGCG) Levels in Nonmalignant Bladder Tissue (e.g., Normal-appearing Urothelium, Inflammatory Lesions in the Bladder, Sessile Noninvasive Bladder Tumors, and Papillary Noninvasive Bladder Tumors)
Hide Description Comparison of nonmalignant bladder tissue levels of EGCG between the placebo group and the EGCG groups combined using student t-test.
Time Frame up to 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Placebo) Arm II (800mg Polyphenon E, Placebo) Arm III (1200mg Polyphenon E)
Hide Arm/Group Description:

Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.

placebo: Given orally

pharmacological study: Correlative studies

laboratory biomarker analysis: Correlative studies

Patients receive four oral 800mg polyphenon E capsules and two oral placebo capsules once daily for 14-28 days in the absence of unacceptable toxicity.After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.

defined green tea catechin extract: Given orally

placebo: Given orally

pharmacological study: Correlative studies

laboratory biomarker analysis: Correlative studies

Patients receive six oral 1200mg polyphenon E capsules once daily for 14-28 days in the absence of unacceptable toxicity. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.

defined green tea catechin extract: Given orally

therapeutic conventional surgery: Undergo surgery

pharmacological study: Correlative studies

laboratory biomarker analysis: Correlative studies

Overall Number of Participants Analyzed 9 8 8
Mean (Standard Error)
Unit of Measure: ng/mL
0.00  (0.00) 0.50  (1.42) 1.72  (3.11)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Placebo), Arm II (800mg Polyphenon E, Placebo), Arm III (1200mg Polyphenon E)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.046
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Secondary Outcome
Title Levels of EGCG in Malignant Bladder Tissue
Hide Description [Not Specified]
Time Frame up to 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was not able to be completed for 1 participant in Arm I, 1 participant in Arm II, and 3 participants in Arm III.
Arm/Group Title Arm I (Placebo) Arm II (800mg Polyphenon E, Placebo) Arm III (1200mg Polyphenon E)
Hide Arm/Group Description:

Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.

placebo: Given orally

pharmacological study: Correlative studies

laboratory biomarker analysis: Correlative studies

Patients receive four oral 800mg polyphenon E capsules and two oral placebo capsules once daily for 14-28 days in the absence of unacceptable toxicity.After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.

defined green tea catechin extract: Given orally

placebo: Given orally

pharmacological study: Correlative studies

laboratory biomarker analysis: Correlative studies

Patients receive six oral 1200mg polyphenon E capsules once daily for 14-28 days in the absence of unacceptable toxicity. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.

defined green tea catechin extract: Given orally

therapeutic conventional surgery: Undergo surgery

pharmacological study: Correlative studies

laboratory biomarker analysis: Correlative studies

Overall Number of Participants Analyzed 10 7 7
Mean (Standard Deviation)
Unit of Measure: ng/mL
0.00  (0.00) 0.00  (0.00) 2.54  (2.92)
3.Secondary Outcome
Title Levels of Surrogate Intermediate Endpoint Biomarkers in Malignant and Nonmalignant Bladder Tissue Assessed by Immunohistochemistry
Hide Description [Not Specified]
Time Frame up to 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Placebo) Arm II (800mg Polyphenon E, Placebo) Arm III (1200mg Polyphenon E)
Hide Arm/Group Description:

Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.

placebo: Given orally

pharmacological study: Correlative studies

laboratory biomarker analysis: Correlative studies

Patients receive four oral 800mg polyphenon E capsules and two oral placebo capsules once daily for 14-28 days in the absence of unacceptable toxicity.After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.

defined green tea catechin extract: Given orally

placebo: Given orally

pharmacological study: Correlative studies

laboratory biomarker analysis: Correlative studies

Patients receive six oral 1200mg polyphenon E capsules once daily for 14-28 days in the absence of unacceptable toxicity. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.

defined green tea catechin extract: Given orally

therapeutic conventional surgery: Undergo surgery

pharmacological study: Correlative studies

laboratory biomarker analysis: Correlative studies

Overall Number of Participants Analyzed 11 8 10
Mean (Standard Deviation)
Unit of Measure: optical density
PCNA 0.41  (0.052) 0.38  (0.061) 0.35  (0.052)
MMP2 0.16  (0.026) 0.18  (0.054) 0.16  (0.069)
Clusterin 0.074  (0.032) 0.061  (0.020) 0.046  (0.013)
VEGF 0.011  (0.0065) 0.021  (0.0173) 0.013  (0.0066)
p27 0.36  (0.080) 0.35  (0.090) 0.31  (0.057)
4.Secondary Outcome
Title Serum Insulin Growth Factor-1 (IGF-1) Levels Assessed by ELISA
Hide Description [Not Specified]
Time Frame Baseline and up to day 28
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was not able to be completed for 2 participants in Arm I.
Arm/Group Title Arm I (Placebo) Arm II (800mg Polyphenon E, Placebo) Arm III (1200mg Polyphenon E)
Hide Arm/Group Description:

Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.

placebo: Given orally

pharmacological study: Correlative studies

laboratory biomarker analysis: Correlative studies

Patients receive four oral 800mg polyphenon E capsules and two oral placebo capsules once daily for 14-28 days in the absence of unacceptable toxicity.After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.

defined green tea catechin extract: Given orally

placebo: Given orally

pharmacological study: Correlative studies

laboratory biomarker analysis: Correlative studies

Patients receive six oral 1200mg polyphenon E capsules once daily for 14-28 days in the absence of unacceptable toxicity. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.

defined green tea catechin extract: Given orally

therapeutic conventional surgery: Undergo surgery

pharmacological study: Correlative studies

laboratory biomarker analysis: Correlative studies

Overall Number of Participants Analyzed 9 8 10
Mean (Standard Deviation)
Unit of Measure: ng/mL
Baseline 135.06  (22.64) 122.22  (37.49) 132.12  (15.12)
End of Study 131.86  (15.59) 124.22  (38.06) 132.27  (27.77)
5.Secondary Outcome
Title Levels of Other Catechins (Epicatechin Gallate, Epicatechin, and Epigallocatechin) Found in Polyphenon E Tumor Tissue Samples
Hide Description [Not Specified]
Time Frame up to 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was not able to be completed for 1 participant in Arm I, 1 participant in Arm II, and 3 participants in Arm III.
Arm/Group Title Arm I (Placebo) Arm II (800mg Polyphenon E, Placebo) Arm III (1200mg Polyphenon E)
Hide Arm/Group Description:

Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.

placebo: Given orally

pharmacological study: Correlative studies

laboratory biomarker analysis: Correlative studies

Patients receive four oral 800mg polyphenon E capsules and two oral placebo capsules once daily for 14-28 days in the absence of unacceptable toxicity.After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.

defined green tea catechin extract: Given orally

placebo: Given orally

pharmacological study: Correlative studies

laboratory biomarker analysis: Correlative studies

Patients receive six oral 1200mg polyphenon E capsules once daily for 14-28 days in the absence of unacceptable toxicity. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.

defined green tea catechin extract: Given orally

therapeutic conventional surgery: Undergo surgery

pharmacological study: Correlative studies

laboratory biomarker analysis: Correlative studies

Overall Number of Participants Analyzed 10 7 7
Mean (Standard Deviation)
Unit of Measure: ng/mL
epicatechin gallate (ECG) 0.00  (0.00) 0.00  (0.00) 0.00  (0.00)
epicatechin (EC) 0.00  (0.00) 0.00  (0.00) 0.00  (0.00)
epigallocatechin (EGC) 0.00  (0.00) 0.00  (0.00) 0.60  (1.58)
6.Secondary Outcome
Title Absolute Change for Baseline From EGCG in Serum Samples
Hide Description The difference between the amount at the end of study (up to 28 days) from baseline.
Time Frame Baseline and up to 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was not able to be completed for 2 participants in Arm I and 1 participant in Arm II.
Arm/Group Title Arm I (Placebo) Arm II (800mg Polyphenon E, Placebo) Arm III (1200mg Polyphenon E)
Hide Arm/Group Description:

Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.

placebo: Given orally

pharmacological study: Correlative studies

laboratory biomarker analysis: Correlative studies

Patients receive four oral 800mg polyphenon E capsules and two oral placebo capsules once daily for 14-28 days in the absence of unacceptable toxicity.After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.

defined green tea catechin extract: Given orally

placebo: Given orally

pharmacological study: Correlative studies

laboratory biomarker analysis: Correlative studies

Patients receive six oral 1200mg polyphenon E capsules once daily for 14-28 days in the absence of unacceptable toxicity. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.

defined green tea catechin extract: Given orally

therapeutic conventional surgery: Undergo surgery

pharmacological study: Correlative studies

laboratory biomarker analysis: Correlative studies

Overall Number of Participants Analyzed 9 7 10
Mean (Standard Deviation)
Unit of Measure: ng/mL
0.28  (1.11) 82.33  (83.66) 85.37  (76.34)
7.Secondary Outcome
Title Metabolism of EGCG in Serum and Urine in Relation to Pharmacogenetic Polymorphisms in Catechol-O-Methyltransferase (COMT)
Hide Description [Not Specified]
Time Frame At Baseline
Hide Outcome Measure Data
Hide Analysis Population Description

This outcome was assessed in all participants,combined irrespective of their randomization.

Analysis was not able to be completed on 4 participants.

Arm/Group Title Glycine/Glycine Alanine/Glycine Alanine/Alanine
Hide Arm/Group Description:
G to G transition in the COMT gene
A to G transition in the COMT gene
A to A transition in the COMT gene
Overall Number of Participants Analyzed 6 11 8
Mean (Standard Deviation)
Unit of Measure: ng/mL
Plasma 4.12  (4.80) 0.57  (1.89) 2.48  (3.48)
Serum 0.00  (0.00) 0.69  (1.82) 0.43  (1.21)
8.Secondary Outcome
Title Serum IGFBP-3 Levels Assessed by ELISA
Hide Description [Not Specified]
Time Frame Baseline and up to 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was not able to be completed for 2 participants in Arm I.
Arm/Group Title Arm I (Placebo) Arm II (800mg Polyphenon E, Placebo) Arm III (1200mg Polyphenon E)
Hide Arm/Group Description:

Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.

placebo: Given orally

pharmacological study: Correlative studies

laboratory biomarker analysis: Correlative studies

Patients receive four oral 800mg polyphenon E capsules and two oral placebo capsules once daily for 14-28 days in the absence of unacceptable toxicity.After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.

defined green tea catechin extract: Given orally

placebo: Given orally

pharmacological study: Correlative studies

laboratory biomarker analysis: Correlative studies

Patients receive six oral 1200mg polyphenon E capsules once daily for 14-28 days in the absence of unacceptable toxicity. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.

defined green tea catechin extract: Given orally

therapeutic conventional surgery: Undergo surgery

pharmacological study: Correlative studies

laboratory biomarker analysis: Correlative studies

Overall Number of Participants Analyzed 9 8 10
Mean (Standard Deviation)
Unit of Measure: ng/mL
Baseline 1918.31  (607.16) 1679.61  (556.59) 1824.86  (559.58)
End of Study 2020.31  (701.46) 1800.08  (490.92) 1624.03  (611.89)
9.Secondary Outcome
Title Levels of Other Catechins (Epicatechin Gallate, Epicatechin, and Epigallocatechin) Found in Polyphenon E Normal Tissue Samples
Hide Description [Not Specified]
Time Frame up to 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was not able to be completed for 2 participants in Arm I and 2 participants in Arm III.
Arm/Group Title Arm I (Placebo) Arm II (800mg Polyphenon E, Placebo) Arm III (1200mg Polyphenon E)
Hide Arm/Group Description:

Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.

placebo: Given orally

pharmacological study: Correlative studies

laboratory biomarker analysis: Correlative studies

Patients receive four oral 800mg polyphenon E capsules and two oral placebo capsules once daily for 14-28 days in the absence of unacceptable toxicity.After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.

defined green tea catechin extract: Given orally

placebo: Given orally

pharmacological study: Correlative studies

laboratory biomarker analysis: Correlative studies

Patients receive six oral 1200mg polyphenon E capsules once daily for 14-28 days in the absence of unacceptable toxicity. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.

defined green tea catechin extract: Given orally

therapeutic conventional surgery: Undergo surgery

pharmacological study: Correlative studies

laboratory biomarker analysis: Correlative studies

Overall Number of Participants Analyzed 9 8 8
Mean (Standard Deviation)
Unit of Measure: ng/mL
epicatechin gallate (ECG) 0.00  (0.00) 0.00  (0.00) 0.00  (0.00)
epicatechin (EC) 0.00  (0.00) 0.00  (0.00) 0.20  (0.55)
epigallocatechin (EGC) 0.00  (0.00) 0.20  (0.55) 0.00  (0.00)
10.Secondary Outcome
Title Absolute Change From Baseline of Other Catechins (Epicatechin Gallate, Epicatechin, and Epigallocatechin) Found in Polyphenon E in Urine Samples
Hide Description The difference between the amount at the end of study (up to 28 days) from baseline.
Time Frame Baseline and up to 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was not able to be completed for 3 participants in Arm I and 1 participant in Arm II.
Arm/Group Title Arm I (Placebo) Arm II (800mg Polyphenon E, Placebo) Arm III (1200mg Polyphenon E)
Hide Arm/Group Description:

Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.

placebo: Given orally

pharmacological study: Correlative studies

laboratory biomarker analysis: Correlative studies

Patients receive four oral 800mg polyphenon E capsules and two oral placebo capsules once daily for 14-28 days in the absence of unacceptable toxicity.After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.

defined green tea catechin extract: Given orally

placebo: Given orally

pharmacological study: Correlative studies

laboratory biomarker analysis: Correlative studies

Patients receive six oral 1200mg polyphenon E capsules once daily for 14-28 days in the absence of unacceptable toxicity. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.

defined green tea catechin extract: Given orally

therapeutic conventional surgery: Undergo surgery

pharmacological study: Correlative studies

laboratory biomarker analysis: Correlative studies

Overall Number of Participants Analyzed 8 7 10
Mean (Standard Deviation)
Unit of Measure: ng/mL
epicatechin gallate (ECG) 0.00  (0.00) 1.13  (1.78) 1.49  (2.13)
epicatechin (EC) 0.52  (1.46) 2.41  (3.15) 5.33  (6.78)
Epigallocatechin (EGC) 0.20  (0.55) 3.60  (3.21) 12.16  (11.09)
11.Secondary Outcome
Title Absolute Change From Baseline of Other Catechins (Epicatechin Gallate, Epicatechin, and Epigallocatechin) Found in Polyphenon E Plasma Samples
Hide Description The difference between the amount at the end of study (up to 28 days) from baseline.
Time Frame Baseline and up to 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was not able to be completed for 2 participants in Arm I and 1 participant in Arm II.
Arm/Group Title Arm I (Placebo) Arm II (800mg Polyphenon E, Placebo) Arm III (1200mg Polyphenon E)
Hide Arm/Group Description:

Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.

placebo: Given orally

pharmacological study: Correlative studies

laboratory biomarker analysis: Correlative studies

Patients receive four oral 800mg polyphenon E capsules and two oral placebo capsules once daily for 14-28 days in the absence of unacceptable toxicity.After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.

defined green tea catechin extract: Given orally

placebo: Given orally

pharmacological study: Correlative studies

laboratory biomarker analysis: Correlative studies

Patients receive six oral 1200mg polyphenon E capsules once daily for 14-28 days in the absence of unacceptable toxicity. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.

defined green tea catechin extract: Given orally

therapeutic conventional surgery: Undergo surgery

pharmacological study: Correlative studies

laboratory biomarker analysis: Correlative studies

Overall Number of Participants Analyzed 9 7 10
Mean (Standard Deviation)
Unit of Measure: ng/mL
epicatechin gallate (ECG) 0.17  (0.52) 8.38  (11.03) 8.62  (9.14)
epicatechin (EC) 0.00  (0.00) 0.97  (1.97) 0.31  (0.66)
epigallocatechin (EGC) 0.00  (0.00) 6.93  (10.06) 3.46  (4.04)
12.Secondary Outcome
Title Absolute Change for Baseline of EGCG in Urine Samples
Hide Description The difference between the amount at the end of study (up to 28 days) from baseline.
Time Frame Baseline and up to 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was not able to be completed for 3 participants in Arm I and 1 participant in Arm II.
Arm/Group Title Arm I (Placebo) Arm II (800mg Polyphenon E, Placebo) Arm III (1200mg Polyphenon E)
Hide Arm/Group Description:

Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.

placebo: Given orally

pharmacological study: Correlative studies

laboratory biomarker analysis: Correlative studies

Patients receive four oral 800mg polyphenon E capsules and two oral placebo capsules once daily for 14-28 days in the absence of unacceptable toxicity.After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.

defined green tea catechin extract: Given orally

placebo: Given orally

pharmacological study: Correlative studies

laboratory biomarker analysis: Correlative studies

Patients receive six oral 1200mg polyphenon E capsules once daily for 14-28 days in the absence of unacceptable toxicity. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.

defined green tea catechin extract: Given orally

therapeutic conventional surgery: Undergo surgery

pharmacological study: Correlative studies

laboratory biomarker analysis: Correlative studies

Overall Number of Participants Analyzed 8 7 10
Mean (Standard Deviation)
Unit of Measure: ng/mL
0.00  (0.00) 1.93  (0.98) 3.38  (1.60)
13.Secondary Outcome
Title Metabolism of EGCG in Serum and Urine in Relation to Pharmacogenetic Polymorphisms in Uridinediphosphate- Glucuronosyltransferase (UGT)
Hide Description [Not Specified]
Time Frame At Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome was assessed in all participants,combined irrespective of their randomization. Analysis was not able to be completed for 4 participants.
Arm/Group Title 5/6 Genotype 6/6 Genotype 6/7 Genotype 7/7 Genotype
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Genotype of the UGT in EGCG
Genotype of the UGT in EGCG
Genotype of the UGT in EGCG
Genotype of the UGT in EGCG
Overall Number of Participants Analyzed 2 7 15 1
Mean (Standard Deviation)
Unit of Measure: ng/mL
Plasma 2.97  (4.20) 2.09  (3.75) 2.02  (3.58) 0.00  (0.00)
Urine 1.72  (2.43) 0.86  (2.27) 0.10  (0.40) 0.00  (0.00)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm I (Placebo) Arm II (800mg Polyphenon E, Placebo) Arm III (1200mg Polyphenon E)
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Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.

placebo: Given orally

pharmacological study: Correlative studies

laboratory biomarker analysis: Correlative studies

Patients receive four oral 800mg polyphenon E capsules and two oral placebo capsules once daily for 14-28 days in the absence of unacceptable toxicity.After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.

defined green tea catechin extract: Given orally

placebo: Given orally

pharmacological study: Correlative studies

laboratory biomarker analysis: Correlative studies

Patients receive six oral 1200mg polyphenon E capsules once daily for 14-28 days in the absence of unacceptable toxicity. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.

defined green tea catechin extract: Given orally

therapeutic conventional surgery: Undergo surgery

pharmacological study: Correlative studies

laboratory biomarker analysis: Correlative studies

All-Cause Mortality
Arm I (Placebo) Arm II (800mg Polyphenon E, Placebo) Arm III (1200mg Polyphenon E)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm I (Placebo) Arm II (800mg Polyphenon E, Placebo) Arm III (1200mg Polyphenon E)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/11 (0.00%)      0/10 (0.00%)      0/10 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm I (Placebo) Arm II (800mg Polyphenon E, Placebo) Arm III (1200mg Polyphenon E)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/11 (27.27%)      5/10 (50.00%)      6/10 (60.00%)    
Cardiac disorders       
Sinus bradycardia  1  1/11 (9.09%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0
Hypertension  1  0/11 (0.00%)  0 1/10 (10.00%)  1 1/10 (10.00%)  1
Ear and labyrinth disorders       
Tinnitus  1  0/11 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1
Eye disorders       
photophobia  1  0/11 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1
Gastrointestinal disorders       
Flatulence  1  0/11 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1
heartburn  1  0/11 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1
Nausa  1  0/11 (0.00%)  0 0/10 (0.00%)  0 2/10 (20.00%)  2
taste alteration  1  0/11 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1
abdominal pain  1  0/11 (0.00%)  0 1/10 (10.00%)  4 1/10 (10.00%)  1
anal pain  1  0/11 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1
General disorders       
Fatigue  1  0/11 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0
headache  1  0/11 (0.00%)  0 1/10 (10.00%)  1 4/10 (40.00%)  4
Immune system disorders       
imb  1  0/11 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1
Infections and infestations       
Urinary Tract infection  1  1/11 (9.09%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0
Metabolism and nutrition disorders       
hyperglycemia  1  1/11 (9.09%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0
Musculoskeletal and connective tissue disorders       
back pain  1  0/11 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1
extremity limb pain  1  0/11 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1
joint pain  1  0/11 (0.00%)  0 1/10 (10.00%)  2 1/10 (10.00%)  3
muscle pain  1  0/11 (0.00%)  0 0/10 (0.00%)  0 2/10 (20.00%)  2
pelvis pain  1  0/11 (0.00%)  0 1/10 (10.00%)  2 0/10 (0.00%)  0
Psychiatric disorders       
Anxiety  1  0/11 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1
Renal and urinary disorders       
kidney pain  1  0/11 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0
Skin and subcutaneous tissue disorders       
Flushing  1  0/11 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0
pruritus  1  0/11 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Howard H. Bailey
Organization: University of Wisconsin
Phone: 608-263-8624
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00666562     History of Changes
Other Study ID Numbers: NCI-2009-00906
NCI-2009-00906 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CO06810
CDR0000594276
H-2007-0250
UWI06-8-01 ( Other Identifier: University of Wisconsin Hospital and Clinics )
UWI06-8-01 ( Other Identifier: DCP )
N01CN35153 ( U.S. NIH Grant/Contract )
P30CA014520 ( U.S. NIH Grant/Contract )
First Submitted: April 24, 2008
First Posted: April 25, 2008
Results First Submitted: January 20, 2016
Results First Posted: March 28, 2016
Last Update Posted: November 17, 2017