Ignite Creation Date:
2024-05-05 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00363805
Status:
COMPLETED
Last Update Posted:
2013-11-28
First Post:
2006-08-10
Brief Title:
Green Tea or Polyphenon E in Preventing Lung Cancer in Former Smokers With Chronic Obstructive Pulmonary Disease
Sponsor:
Sherry Chow
Organization:
University of Arizona
Study Overview
Official Title:
Chemoprevention of Lung Carcinogenesis Using Green Tea Phase IIb Randomized Double-Blinded Placebo Controlled Trial of Green Tea and Polyphenon E in Former Smokers With Chronic Obstructive Lung Disease COPD
Status:
COMPLETED
Status Verified Date:
2013-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Chemoprevention is the use of certain substances to keep cancer from forming growing or coming back The use of green tea or polyphenon E may prevent cancer from forming in former smokers with chronic obstructive pulmonary disease
PURPOSE This randomized phase II trial is studying how well green tea or polyphenon E work in preventing lung cancer in former smokers with chronic obstructive pulmonary disease
PURPOSE This randomized phase II trial is studying how well green tea or polyphenon E work in preventing lung cancer in former smokers with chronic obstructive pulmonary disease
Detailed Description:
OBJECTIVES
Primary
Evaluate the effects of high-level oral consumption of defined green tea four 12-oz servingsday or polyphenon E capsules 4 capsulesday on markers of cellular oxidative damage as measured by 8-hydroxydeoxyguanosine 8-OHdG and 8-F_2-isoprostanes 8-epi-PGF2 in former smokers with chronic obstructive pulmonary disease
Secondary
Evaluate the effects of high-level oral consumption of defined green tea or polyphenon E capsules on body antioxidant status carotenoids vitamins A and E ascorbic acid vitamin C and antioxidant enzymes catalase and glutathione peroxidase in blood in these patients
Evaluate the effects of high-level oral consumption of defined green tea or polyphenon E capsules on gene expression of markers of proliferation and apoptosis in induced sputum in these patients
Tertiary
Evaluate the effects of high-level oral consumption of defined green tea or polyphenon E capsules on lung function in these patients
Evaluate the relative adherence to use of green tea beverage vs polyphenon E capsules in these patients
OUTLINE This is a randomized double-blind placebo-controlled study Patients are stratified according to gender and inhaled steroid usage yes vs no
All patients receive placebo tea beverage and placebo capsules 4 times a day for 2 weeks Patients are randomized to 1 of 3 treatment arms after successful completion of the 2-week period
Arm I green tea beverage Patients receive oral green tea beverage and oral polyphenon E placebo daily for 6 months
Arm II green tea capsule polyphenon E Patients receive oral green tea beverage placebo and oral polyphenon E daily for 6 months
Arm III placebo Patients receive oral green tea beverage placebo and oral polyphenon E placebo daily for 6 months
Patients undergo blood urine exhaled breath condensate EBC induced sputum and buccal cell collection at baseline and periodically during study for biomarkerlaboratory analysis Blood samples are analyzed for 8-hydroxydeoxyguanosine 8-OHdG glutathione peroxidase and catalase Urine is examined for F_2-isoprostanes 8-OHdG and tea polyphenols Induced sputum broncho-epithelial cells are analyzed for gene expression of genes implicated in cellular growth and apoptotic pathway via reverse transcriptase-polymerase chain reaction EBC samples are examined for F_2-isoprostane levels Buccal cells are stored for future analysis
PROJECTED ACCRUAL A total of 195 patients will be accrued for this study
Primary
Evaluate the effects of high-level oral consumption of defined green tea four 12-oz servingsday or polyphenon E capsules 4 capsulesday on markers of cellular oxidative damage as measured by 8-hydroxydeoxyguanosine 8-OHdG and 8-F_2-isoprostanes 8-epi-PGF2 in former smokers with chronic obstructive pulmonary disease
Secondary
Evaluate the effects of high-level oral consumption of defined green tea or polyphenon E capsules on body antioxidant status carotenoids vitamins A and E ascorbic acid vitamin C and antioxidant enzymes catalase and glutathione peroxidase in blood in these patients
Evaluate the effects of high-level oral consumption of defined green tea or polyphenon E capsules on gene expression of markers of proliferation and apoptosis in induced sputum in these patients
Tertiary
Evaluate the effects of high-level oral consumption of defined green tea or polyphenon E capsules on lung function in these patients
Evaluate the relative adherence to use of green tea beverage vs polyphenon E capsules in these patients
OUTLINE This is a randomized double-blind placebo-controlled study Patients are stratified according to gender and inhaled steroid usage yes vs no
All patients receive placebo tea beverage and placebo capsules 4 times a day for 2 weeks Patients are randomized to 1 of 3 treatment arms after successful completion of the 2-week period
Arm I green tea beverage Patients receive oral green tea beverage and oral polyphenon E placebo daily for 6 months
Arm II green tea capsule polyphenon E Patients receive oral green tea beverage placebo and oral polyphenon E daily for 6 months
Arm III placebo Patients receive oral green tea beverage placebo and oral polyphenon E placebo daily for 6 months
Patients undergo blood urine exhaled breath condensate EBC induced sputum and buccal cell collection at baseline and periodically during study for biomarkerlaboratory analysis Blood samples are analyzed for 8-hydroxydeoxyguanosine 8-OHdG glutathione peroxidase and catalase Urine is examined for F_2-isoprostanes 8-OHdG and tea polyphenols Induced sputum broncho-epithelial cells are analyzed for gene expression of genes implicated in cellular growth and apoptotic pathway via reverse transcriptase-polymerase chain reaction EBC samples are examined for F_2-isoprostane levels Buccal cells are stored for future analysis
PROJECTED ACCRUAL A total of 195 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UARIZ-HSC-0353 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA023074 |
| U01CA101204 | NIH | None | None |
| P30CA023074 | NIH | None | None |