Lung Cancer PreventionPhase 2NCT00363805
Green Tea or Polyphenon E in Preventing Lung Cancer in Former Smokers With Chronic Obstructive Pulmonary Disease
A Phase 2 study testing green tea and Polyphenon E in people with Lung Cancer Prevention, run by Sherry Chow at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Lung Cancer Prevention
- What is being tested?
- green tea and Polyphenon E
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 178 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2004to Mar 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Diagnosis of chronic obstructive pulmonary disease
- FEV_1/FVC ≤ 78
- History of smoking ≥ 1 pack daily for 30 years OR 2 packs daily for 15 years
- Stopped smoking for ≥ 1 year
- No previously diagnosed bronchiectasis
- No history of > 1 acute emphysema exacerbation within the past 3 months
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- WBC ≥ 3,500/mm³
- Platelet count > 130,000/mm³
- Hemoglobin ≥ 11 g/dL (female) or 12 g/dL (male)
- AST and ALT normal
- Bilirubin ≤ 1.5 mg/dL (unless Gilbert's disease present)
- Creatinine ≤ 1.5 mg/dL
- Alkaline phosphatase ≤ 2 times upper limit of normal
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No invasive cancer within the past 5 years
- Able and willing to consume caffeinated beverages
- Able to produce induced sputum
- Able to perform forced expiratory maneuver during spirometry testing
- No immunosuppression by virtue of medication or disease including, but no limited to, any of the following:
- Organ transplantation
- Liver or kidney failure
- Autoimmune diseases
- Oral steroids
- Chemotherapy
- No serious concurrent illness that could preclude study compliance, such as uncontrolled high blood pressure, heart disease, or poorly controlled diabetes
- No myocardial infarction within the past 6 weeks
PRIOR CONCURRENT THERAPY:
- At least 2 weeks since prior and no concurrent dietary supplements or herbal products, including any of the following:
- Herbal tea
- Ginkgo biloba > 60 mg/day
- Melatonin > 3 mg/day
- Echinacea > 300 mg/day
- Hypericum perforatum (St. John's wort) > 300 mg/day
- DHEA mustard > 5 mg/day
- At least 2 weeks since prior and no concurrent nontrial tea or tea products
- More than 3 weeks since prior chest or abdominal surgery
- More than 3 months since prior participation in chemoprevention or clinical intervention trials
- At least 3 months since prior and no concurrent megadoses of vitamins, defined as > 4,000 IU of vitamin A, 400 IU of vitamin E, 400 IU of cholecalciferol (vitamin D), 60 μg of selenium, or 1,000 mg of ascorbic acid (vitamin C) per day
- No regular consumption of ≥ 6 cups or glasses of tea per week
- No concurrent nontrial caffeine at > 1 serving/day (1 serving defined as 12 oz of regular soda or 8 oz of coffee)
- No concurrent participation in another interventional clinical trial
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea
Tucson, Arizona, 85258
Veterans Affairs Medical Center - Tucson
Tucson, Arizona, 85723
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, 85724-5024
About this study
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)
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.
Read the detailed description
OBJECTIVES:
Primary
- Evaluate the effects of high-level oral consumption of defined green tea (four 12-oz servings/day) or polyphenon E capsules (4 capsules/day) 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 biomarker/laboratory 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.
- Conditions
- Lung Cancer Prevention
- Being tested
- green tea, Polyphenon E, placebo
- Keywords
- lung cancer, prevention, green tea, former smokers
- Medical subject headings
- Lung Neoplasms, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
green teaDietary supplement
Given orally
Polyphenon EDrug
Given orally
placeboOther
Given orally
| Study group | Role | What they receive |
|---|---|---|
| Green Tea | Experimental | Patients receive green tea beverage and placebo capsules for 6 months. Receives: Dietary Supplement: green tea |
| Polyphenon E | Experimental | Patients receive placebo beverage and Polyphenon E capsules daily for 6 months. Receives: Drug: Polyphenon E |
| Placebo | Placebo comparator | Patients receive placebo beverage and placebo capsules daily for 6 months. Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Urinary 8-hydroxydeoxyguanosine Levels
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
Measured: Baseline and 6 months
Change in Urinary 8-F2-isoprostanes Levels
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
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2006 (estimated)
- Study startMay 2004
- Primary completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lung Cancer PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sherry Chow
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, Sherry Chow, University of Arizona
- Investigators
- Iman Hakim, MD, PhD, MPH, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00363805
- Sponsor's protocol ID
- CDR0000487501
- Other IDs
- U01CA101204, P30CA023074, UARIZ-HSC-0353
- Status last verified
- Sep 2013
- First submitted
- 10 Aug 2006
- Last updated
- 28 Nov 2013
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00363805
- Acronym / sponsor ID
- CDR0000487501
- Conditions
- Lung Cancer Prevention
- Keywords
- lung cancer, prevention, green tea, former smokers
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Sherry ChowUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 2004
- Primary completion
- Mar 2009 (actual)
- First posted
- 15 Aug 2006 (estimated)
- Results
- Posted 28 Nov 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
OBJECTIVES:
Primary
- Evaluate the effects of high-level oral consumption of defined green tea (four 12-oz servings/day) or polyphenon E capsules (4 capsules/day) 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 biomarker/laboratory 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Green Tea | Experimental | Dietary Supplement: green teaPatients receive green tea beverage and placebo capsules for 6 months. |
| Polyphenon E | Experimental | Drug: Polyphenon EPatients receive placebo beverage and Polyphenon E capsules daily for 6 months. |
| Placebo | Placebo comparator | Other: placeboPatients receive placebo beverage and placebo capsules daily for 6 months. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| green teaGiven orally | Dietary supplement | Green Tea |
| Polyphenon EGiven orally | Drug | Polyphenon E |
| placeboGiven orally | Other | Placebo |
Primary outcome
Change in Urinary 8-hydroxydeoxyguanosine Levels
Time frame: Baseline and 6 months
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
Change in Urinary 8-F2-isoprostanes Levels
Time frame: Baseline and 6 months
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Lung Cancer Prevention
RecruitingPhase 2
PirfenidoneVsPlacebo as Prophylaxis Against Acute Radiation-induced Lung Injury Following HFRT in Breast Cancer Patients
Acute Lung Injury, Prevention
Recruiting
Akershus Cardiac Examination (ACE) 5 Study
Heavy Smokers, Lung Cancer Screening
RecruitingObservational study
Mobile Lung Cancer Screening
Lung Cancer Prevention
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Iman Hakim, MD, PhD, MPH principal investigator
University of Arizona
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing green tea and Polyphenon E in people with Lung Cancer Prevention, run by Sherry Chow at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Nov 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Urinary 8-hydroxydeoxyguanosine Levels (time frame: Baseline and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2013; AzTrials last refreshed its copy on 6 Nov 2026.