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Polyphenon E in Treating Patients With High-Risk of Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT01606124
Recruitment Status : Terminated (pending expiration of the supply of study agent.)
First Posted : May 25, 2012
Results First Posted : September 28, 2017
Last Update Posted : October 27, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Advanced Colorectal Adenomas
Adenocarcinoma of the Colon
Stage I Colon Cancer
Stage II Colon Cancer
Stage III Colon Cancer
Interventions Drug: defined green tea catechin extract
Other: placebo
Other: questionnaire administration
Other: laboratory biomarker analysis
Enrollment 39
Recruitment Details The study was closed to accrual early due to a pending expiration of the supply of study agent.
Pre-assignment Details  
Arm/Group Title Arm I (Polyphenon E) Arm II (Placebo)
Hide Arm/Group Description Patients receive two capsules Polyphenon E (each capsule of Polyphenon E contains approximately 200 mg epigallocatechin gallate (EGCG)) PO BID. Courses repeat every 28 days for 6 months in the absence of disease progression or unacceptable toxicity. Patients receive two capsules placebo PO BID. Courses repeat every 28 days for 6 months in the absence of disease progression or unacceptable toxicity.
Period Title: Overall Study
Started 19 20
Completed 19 20
Not Completed 0 0
Arm/Group Title Arm I (Polyphenon E) Arm II (Placebo) Total
Hide Arm/Group Description Patients receive two capsules Polyphenon E (each capsule of Polyphenon E contains approximately 200 mg epigallocatechin gallate (EGCG)) PO BID. Courses repeat every 28 days for 6 months in the absence of disease progression or unacceptable toxicity. Patients receive two capsules placebo PO BID. Courses repeat every 28 days for 6 months in the absence of disease progression or unacceptable toxicity. Total of all reporting groups
Overall Number of Baseline Participants 19 20 39
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants 20 participants 39 participants
58.5  (17.0) 61.4  (7.9) 59.9  (13.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 20 participants 39 participants
Female
6
  31.6%
8
  40.0%
14
  35.9%
Male
13
  68.4%
12
  60.0%
25
  64.1%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 19 participants 20 participants 39 participants
19
 100.0%
20
 100.0%
39
 100.0%
1.Primary Outcome
Title Percent Change in Rectal ACF, Pre- and Post Intervention at 6 Months
Hide Description The primary endpoint is based on a modified intent-to-treat procedure which includes all patients with baseline and 6-month ACF data. The percent change in rectal ACF (≤ 15 cm from the anal verge) for each patient is calculated as their Pre-Registration number of rectal ACF minus the number of rectal ACF present at the 6-month post-intervention exam, divided by the number of rectal ACF present at Pre-Registration times 100.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with baseline and 6-month ACF data were included in this analysis.
Arm/Group Title Arm I (Polyphenon E) Arm II (Placebo)
Hide Arm/Group Description:
Patients receive two capsules Polyphenon E (each capsule of Polyphenon E contains approximately 200 mg epigallocatechin gallate (EGCG)) PO BID. Courses repeat every 28 days for 6 months in the absence of disease progression or unacceptable toxicity.
Patients receive two capsules placebo PO BID. Courses repeat every 28 days for 6 months in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 15 17
Mean (Standard Deviation)
Unit of Measure: percentage change
3.7  (49.1) 0.0  (62.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Polyphenon E), Arm II (Placebo)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5631
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Secondary Outcome
Title Tolerability as Estimated Using the Percent Dose of Treatment Received at 6 Months
Hide Description Tolerability as estimated using the percent dose of treatment received for each patient by dividing the total dose received by the targeted (i.e., protocol specified) total dose.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Polyphenon E) Arm II (Placebo)
Hide Arm/Group Description:
Patients receive two capsules Polyphenon E (each capsule of Polyphenon E contains approximately 200 mg epigallocatechin gallate (EGCG)) PO BID. Courses repeat every 28 days for 6 months in the absence of disease progression or unacceptable toxicity.
Patients receive two capsules placebo PO BID. Courses repeat every 28 days for 6 months in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 19 20
Mean (Standard Deviation)
Unit of Measure: percentage of targeted dose
83.2  (29.3) 91.7  (24.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Polyphenon E), Arm II (Placebo)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1439
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame 6 months
Adverse Event Reporting Description CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
 
Arm/Group Title Arm I (Polyphenon E) Arm II (Placebo)
Hide Arm/Group Description Patients receive two capsules Polyphenon E (each capsule of Polyphenon E contains approximately 200 mg epigallocatechin gallate (EGCG)) PO BID. Courses repeat every 28 days for 6 months in the absence of disease progression or unacceptable toxicity. Patients receive two capsules placebo PO BID. Courses repeat every 28 days for 6 months in the absence of disease progression or unacceptable toxicity.
All-Cause Mortality
Arm I (Polyphenon E) Arm II (Placebo)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)      0/20 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Arm I (Polyphenon E) Arm II (Placebo)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/19 (0.00%)      0/20 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm I (Polyphenon E) Arm II (Placebo)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/19 (21.05%)      1/20 (5.00%)    
Gastrointestinal disorders     
Abdominal pain  1  0/19 (0.00%)  0 1/20 (5.00%)  6
Diarrhea  1  1/19 (5.26%)  1 0/20 (0.00%)  0
Dyspepsia  1  0/19 (0.00%)  0 1/20 (5.00%)  6
Nausea  1  2/19 (10.53%)  2 1/20 (5.00%)  6
General disorders     
Fatigue  1  0/19 (0.00%)  0 1/20 (5.00%)  6
Flu like symptoms  1  0/19 (0.00%)  0 1/20 (5.00%)  6
Investigations     
Alanine aminotransferase increased  1  1/19 (5.26%)  1 0/20 (0.00%)  0
Aspartate aminotransferase increased  1  1/19 (5.26%)  1 0/20 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Myalgia  1  0/19 (0.00%)  0 1/20 (5.00%)  6
Nervous system disorders     
Dizziness  1  0/19 (0.00%)  0 1/20 (5.00%)  6
Headache  1  0/19 (0.00%)  0 1/20 (5.00%)  6
1
Term from vocabulary, MedDRA 12
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Frank A. Sinicrope, M.D.
Organization: Mayo Clinic
Phone: 507-284–2511
Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT01606124     History of Changes
Obsolete Identifiers: NCT01974960
Other Study ID Numbers: MC084C
NCI-2012-00058 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Submitted: May 23, 2012
First Posted: May 25, 2012
Results First Submitted: August 28, 2017
Results First Posted: September 28, 2017
Last Update Posted: October 27, 2017