Trial Outcomes & Findings for Green Tea or Polyphenon E in Preventing Lung Cancer in Former Smokers With Chronic Obstructive Pulmonary Disease (NCT NCT00363805)
NCT ID: NCT00363805
Last Updated: 2013-11-28
Results Overview
the urinary concentrations of 8-hydroxydeoxyguanosine were normalized by the urinary creatinine concentrations to correct for variations in urine dilution/production and the change in urinary 8-hydroxydeoxyguanosine levels was calculated as the 6 months levels minus the baseline levels
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
178 participants
Primary outcome timeframe
Baseline and 6 months
Results posted on
2013-11-28
Participant Flow
Participant milestones
| Measure |
Green Tea
Patients receive green tea beverage and placebo capsules for 6 months.
|
Polyphenon E
Patients receive placebo beverage and Polyphenon E capsules daily for 6 months.
|
Placebo
Patients receive placebo beverage and placebo capsules daily for 6 months.
|
|---|---|---|---|
|
Overall Study
STARTED
|
42
|
63
|
73
|
|
Overall Study
COMPLETED
|
38
|
57
|
70
|
|
Overall Study
NOT COMPLETED
|
4
|
6
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Green Tea or Polyphenon E in Preventing Lung Cancer in Former Smokers With Chronic Obstructive Pulmonary Disease
Baseline characteristics by cohort
| Measure |
Green Tea
n=42 Participants
Patients receive green tea beverage and placebo capsules for 6 months.
|
Polyphenon E
n=63 Participants
Patients receive placebo beverage and Polyphenon E capsules daily for 6 months.
|
Placebo
n=73 Participants
Patients receive placebo beverage and placebo capsules daily for 6 months.
|
Total
n=178 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
85 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
26 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
93 Participants
n=4 Participants
|
|
Age Continuous
|
66.8 years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
63.6 years
STANDARD_DEVIATION 8.5 • n=7 Participants
|
64.3 years
STANDARD_DEVIATION 7.8 • n=5 Participants
|
64.7 years
STANDARD_DEVIATION 8.5 • n=4 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
89 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
89 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
42 participants
n=5 Participants
|
63 participants
n=7 Participants
|
73 participants
n=5 Participants
|
178 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and 6 monthsPopulation: The number of participants analyzed was less than the number of participants completing the study because the analysis only included samples where the identify of the analyte was confirmed in the sample.
the urinary concentrations of 8-hydroxydeoxyguanosine were normalized by the urinary creatinine concentrations to correct for variations in urine dilution/production and the change in urinary 8-hydroxydeoxyguanosine levels was calculated as the 6 months levels minus the baseline levels
Outcome measures
| Measure |
Green Tea
n=33 Participants
Patients receive green tea beverage and placebo capsules for 6 months.
|
Polyphenon E
n=51 Participants
Patients receive placebo beverage and Polyphenon E capsules daily for 6 months.
|
Placebo
n=67 Participants
Patients receive placebo beverage and placebo capsules daily for 6 months.
|
|---|---|---|---|
|
Change in Urinary 8-hydroxydeoxyguanosine Levels
|
2.36 ng/mg creatinine
Standard Deviation 10.48
|
5.20 ng/mg creatinine
Standard Deviation 36.20
|
-1.08 ng/mg creatinine
Standard Deviation 25.41
|
PRIMARY outcome
Timeframe: Baseline and 6 monthsPopulation: The number of participants analyzed was less than the number of participants completing the study because the analysis only included samples where the identity of the analyte was confirmed in the sample.
the urinary concentrations of 8-F2-isoprostanes were normalized by the urinary creatinine concentrations to correct for variations in urine dilution/production and the change in urinary 8-F2-isoprostanes levels was calculated as 6 months levels minus baseline levels
Outcome measures
| Measure |
Green Tea
n=30 Participants
Patients receive green tea beverage and placebo capsules for 6 months.
|
Polyphenon E
n=51 Participants
Patients receive placebo beverage and Polyphenon E capsules daily for 6 months.
|
Placebo
n=66 Participants
Patients receive placebo beverage and placebo capsules daily for 6 months.
|
|---|---|---|---|
|
Change in Urinary 8-F2-isoprostanes Levels
|
-39.87 ng/mg creatinine
Standard Deviation 271.2
|
-35.80 ng/mg creatinine
Standard Deviation 261.7
|
0.71 ng/mg creatinine
Standard Deviation 266.4
|
Adverse Events
Green Tea
Serious events: 4 serious events
Other events: 12 other events
Deaths: 0 deaths
Polyphenon E
Serious events: 4 serious events
Other events: 14 other events
Deaths: 0 deaths
Placebo
Serious events: 7 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Green Tea
n=42 participants at risk
Patients receive green tea beverage and placebo capsules for 6 months.
|
Polyphenon E
n=63 participants at risk
Patients receive placebo beverage and Polyphenon E capsules daily for 6 months.
|
Placebo
n=73 participants at risk
Patients receive placebo beverage and placebo capsules daily for 6 months.
|
|---|---|---|---|
|
Cardiac disorders
cardiac arrest
|
0.00%
0/42
|
0.00%
0/63
|
1.4%
1/73
|
|
Cardiac disorders
chest pain
|
0.00%
0/42
|
0.00%
0/63
|
1.4%
1/73
|
|
Surgical and medical procedures
other - knee surgery
|
0.00%
0/42
|
0.00%
0/63
|
1.4%
1/73
|
|
Respiratory, thoracic and mediastinal disorders
aspiration
|
0.00%
0/42
|
1.6%
1/63
|
4.1%
3/73
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
2.4%
1/42
|
1.6%
1/63
|
0.00%
0/73
|
|
Respiratory, thoracic and mediastinal disorders
other - emphysema
|
2.4%
1/42
|
0.00%
0/63
|
0.00%
0/73
|
|
Infections and infestations
bronchial infection
|
2.4%
1/42
|
1.6%
1/63
|
0.00%
0/73
|
|
Infections and infestations
other - pneumonia
|
0.00%
0/42
|
0.00%
0/63
|
1.4%
1/73
|
|
General disorders
Flu-like symptoms
|
2.4%
1/42
|
0.00%
0/63
|
0.00%
0/73
|
|
Cardiac disorders
pacemaker placement
|
2.4%
1/42
|
0.00%
0/63
|
0.00%
0/73
|
|
Surgical and medical procedures
Other - replacement of implant stimulator in abdomen
|
0.00%
0/42
|
0.00%
0/63
|
1.4%
1/73
|
|
Surgical and medical procedures
Other - surgery for unclogging carotid artery
|
0.00%
0/42
|
0.00%
0/63
|
1.4%
1/73
|
|
Surgical and medical procedures
Other - knee replacement
|
2.4%
1/42
|
0.00%
0/63
|
0.00%
0/73
|
|
Surgical and medical procedures
Other - placement of coronary stent
|
0.00%
0/42
|
1.6%
1/63
|
0.00%
0/73
|
|
Surgical and medical procedures
Other - surgery on right ankle
|
0.00%
0/42
|
1.6%
1/63
|
0.00%
0/73
|
|
Infections and infestations
Skin infection
|
2.4%
1/42
|
0.00%
0/63
|
0.00%
0/73
|
|
Blood and lymphatic system disorders
Other - blood clotting disorder
|
2.4%
1/42
|
0.00%
0/63
|
0.00%
0/73
|
Other adverse events
| Measure |
Green Tea
n=42 participants at risk
Patients receive green tea beverage and placebo capsules for 6 months.
|
Polyphenon E
n=63 participants at risk
Patients receive placebo beverage and Polyphenon E capsules daily for 6 months.
|
Placebo
n=73 participants at risk
Patients receive placebo beverage and placebo capsules daily for 6 months.
|
|---|---|---|---|
|
Nervous system disorders
dizziness
|
9.5%
4/42
|
3.2%
2/63
|
4.1%
3/73
|
|
Nervous system disorders
headache
|
9.5%
4/42
|
6.3%
4/63
|
5.5%
4/73
|
|
General disorders
Flu-like symptoms
|
14.3%
6/42
|
12.7%
8/63
|
17.8%
13/73
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
11.9%
5/42
|
7.9%
5/63
|
4.1%
3/73
|
|
Gastrointestinal disorders
dyspepsia
|
4.8%
2/42
|
6.3%
4/63
|
5.5%
4/73
|
|
Gastrointestinal disorders
gastroesophageal reflux disease
|
9.5%
4/42
|
4.8%
3/63
|
1.4%
1/73
|
|
Gastrointestinal disorders
nausea
|
9.5%
4/42
|
4.8%
3/63
|
0.00%
0/73
|
|
Gastrointestinal disorders
constipation
|
0.00%
0/42
|
6.3%
4/63
|
0.00%
0/73
|
|
Vascular disorders
hypertension
|
7.1%
3/42
|
0.00%
0/63
|
4.1%
3/73
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place