Lung CancerPhase 2NCT00573885
Green Tea Extract in Preventing Cancer in Former and Current Heavy Smokers With Abnormal Sputum
A Phase 2 study testing defined green tea catechin extract in people with Lung Cancer and Tobacco Use Disorder, run by British Columbia Cancer Agency at 1 site in Canada.
Trial summary
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. Green tea extract may keep cancer from forming. PURPOSE: This randomized phase II trial is studying green tea extract in preventing cancer in former and current heavy smokers with abnormal sputum. Read more about this study
- Who is it for?
- Ages 45 to 74 years
- Conditions the study is for
- Lung Cancer, Tobacco Use Disorder
- What is being tested?
- defined green tea catechin extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2008to Dec 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 45 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ECOG performance status 0-1
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Creatinine normal
- Bilirubin normal
- AST and ALT normal
- Alkaline phosphatase normal
Who cannot join
- Chronic active hepatitis/liver cirrhosis
- Severe heart disease (e.g., unstable angina, chronic congestive heart failure, use of antiarrhythmic agents)
- Ongoing gastric ulcer
- Acute bronchitis or pneumonia within one month
- Known reaction to lidocaine, albuterol sulfate, midazolam hydrochloride, and/or alfentanil hydrochloride
- Known allergy to green tea and/or corn starch, gelatin, or other nonmedicinal ingredients
Show all 13Show fewer
- Any medical condition, such as acute or chronic respiratory failure or bleeding disorder that, in the opinion of the investigator, could jeopardize the patient's safety during participation in the study
- Unwilling to have a bronchoscopy
- Unwilling to have a spiral chest CT
- PRIOR CONCURRENT THERAPY:
- No more than 5 cups of tea a week
- No concurrent anticoagulant treatment such as warfarin or heparin
- No use of other natural health products containing green tea compounds
Trial locations and contacts
1 site in 1 country.
Canada1 site
British Columbia Cancer Agency - Vancouver Cancer Centre
Vancouver, British Columbia, V5Z 4E6
About this study
Official title: Phase II Trial of Polyphenon E in Former Smokers With Abnormal Sputa
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. Green tea extract may keep cancer from forming.
PURPOSE: This randomized phase II trial is studying green tea extract in preventing cancer in former and current heavy smokers with abnormal sputum.
Read the detailed description
OBJECTIVES:
- Evaluate the efficacy and safety of defined green tea catechin extract (polyphenon E) in former smokers with abnormal sputum score using stringent, newly developed response criteria of combined nuclear morphometry and malignancy-associated changes as the primary surrogate endpoint.
- Evaluate if polyphenon E can modulate other surrogate endpoint biomarkers of aberrant methylation, cell cycle regulation, apoptosis, oncogene/tumor suppressor gene expression, as well as phase I and II enzyme regulation.
- Establish a library of in-vivo confocal micro-endoscopy and optical coherent tomography images of the bronchial epithelium with corresponding histopathology, nuclear morphometry, and other biomarker information to assess the potential of confocal micro-endoscopy as a non-biopsy method to assess the effect of chemoprevention agents.
OUTLINE: This is an open label, part 1 study followed by a randomized, double-blind, part 2 study.
- Part 1 (completed March 22, 2006): Patients receive oral defined green tea catechin extract twice daily in months 1 and 2 and inhaled budesonide twice daily in month 2.
Patients undergo autofluorescence bronchoscopy with biopsies, oral and bronchial brushing, and bronchoalveolar lavage at the end of months 1 and 2.
- Part 2: Patients are stratified by gender and randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral defined green tea catechin extract twice daily for 6 months.
- Arm II: Patients receive oral placebo twice daily for 6 months. Patients who have progressive or stable disease at 6 months may receive open-label defined green tea catechin extract.
Patients undergo autofluorescence bronchoscopy with biopsies, oral and bronchial brushing, and bronchoalveolar lavage at the end of months 6 and 12.
Blood samples are collected periodically for biomarker studies. After completion of study therapy, patients are followed periodically for 6 months.
- Conditions
- Lung Cancer, Tobacco Use Disorder
- Being tested
- defined green tea catechin extract, placebo
- Keywords
- non-small cell lung cancer, small cell lung cancer, tobacco use disorder
- Medical subject headings
- Lung Neoplasms, Tobacco Use Disorder, Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
defined green tea catechin extractDrug
Given orally
placeboOther
Given orally
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients receive oral defined green tea catechin extract twice daily for 6 months. Receives: Drug: defined green tea catechin extract |
| Arm II | Placebo comparator | Patients receive oral placebo twice daily for 6 months. Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in oncogene/tumor suppression gene expression (part 1; completed March 22, 2006)
Measured: 36 months
Phase I and II enzyme regulation by Affymetrix chip analysis in bronchial brush cells (part 1)
Measured: 60 months
C-reactive protein level in plasma before treatment and 1 and 2 months after treatment (part 1)
Measured: 60 months
Quantitative sputum score by image analysis before and 6 months after treatment (part 2)
Measured: 36 months
Secondary outcomes (9)
Change in pathology grade of bronchial biopsies (part 2)
Measured: 36 months
Morphometric index of bronchial biopsies and bronchoalveolar lavage cells (BAL) (part 2)
Measured: 36 months
Methylation markers in sputa and BAL cells (part 2)
Measured: 60 months
Ki-67 expression (part 2)
Measured: 60 months
Cleaved caspase 3, p53, and VEGF assays in bronchial biopsies (part 2)
Measured: 60 months
Oncogene and tumor suppression gene expression (part 2)
Measured: 60 months
Phase I and II enzyme regulation by Affymetrix chip analysis of RNA from bronchial brush cells (part 2)
Measured: 60 months
C-reactive protein levels in plasma before treatment, and 6 months after treatment (part 2)
Measured: 36 months
Resolution or progression of non-calcified lung nodules on spiral CT (part 2)
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2007 (estimated)
- Study startJan 2008
- Primary completionNov 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by British Columbia Cancer AgencyThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- British Columbia Cancer Agency
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), University of Cincinnati
- Responsible party
- Sponsor
- Investigators
- Stephen Lam, MD, Study chair, British Columbia Cancer Agency
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00573885
- Sponsor's protocol ID
- CDR0000578191
- Other IDs
- P01CA096964, BCCA-H03-61083, BCCA-R03-1083
- Status last verified
- Mar 2012
- First submitted
- 13 Dec 2007
- Last updated
- 9 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Polyphenon E in Former Smokers With Abnormal Sputa
- ClinicalTrials.gov ID
- NCT00573885
- Acronym / sponsor ID
- CDR0000578191
- Conditions
- Lung Cancer, Tobacco Use Disorder
- Keywords
- non-small cell lung cancer, small cell lung cancer, tobacco use disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- British Columbia Cancer AgencyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), University of Cincinnati
- Study start
- Jan 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 14 Dec 2007 (estimated)
- Results
- Not posted in the source record
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 drugs to keep cancer from forming. Green tea extract may keep cancer from forming.
PURPOSE: This randomized phase II trial is studying green tea extract in preventing cancer in former and current heavy smokers with abnormal sputum.
Detailed description
OBJECTIVES:
- Evaluate the efficacy and safety of defined green tea catechin extract (polyphenon E) in former smokers with abnormal sputum score using stringent, newly developed response criteria of combined nuclear morphometry and malignancy-associated changes as the primary surrogate endpoint.
- Evaluate if polyphenon E can modulate other surrogate endpoint biomarkers of aberrant methylation, cell cycle regulation, apoptosis, oncogene/tumor suppressor gene expression, as well as phase I and II enzyme regulation.
- Establish a library of in-vivo confocal micro-endoscopy and optical coherent tomography images of the bronchial epithelium with corresponding histopathology, nuclear morphometry, and other biomarker information to assess the potential of confocal micro-endoscopy as a non-biopsy method to assess the effect of chemoprevention agents.
OUTLINE: This is an open label, part 1 study followed by a randomized, double-blind, part 2 study.
- Part 1 (completed March 22, 2006): Patients receive oral defined green tea catechin extract twice daily in months 1 and 2 and inhaled budesonide twice daily in month 2.
Patients undergo autofluorescence bronchoscopy with biopsies, oral and bronchial brushing, and bronchoalveolar lavage at the end of months 1 and 2.
- Part 2: Patients are stratified by gender and randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral defined green tea catechin extract twice daily for 6 months.
- Arm II: Patients receive oral placebo twice daily for 6 months. Patients who have progressive or stable disease at 6 months may receive open-label defined green tea catechin extract.
Patients undergo autofluorescence bronchoscopy with biopsies, oral and bronchial brushing, and bronchoalveolar lavage at the end of months 6 and 12.
Blood samples are collected periodically for biomarker studies. After completion of study therapy, patients are followed periodically for 6 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Drug: defined green tea catechin extractPatients receive oral defined green tea catechin extract twice daily for 6 months. |
| Arm II | Placebo comparator | Other: placeboPatients receive oral placebo twice daily for 6 months. |
Who may qualify
- Ages
- 45 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- ECOG performance status 0-1
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Creatinine normal
Key exclusion criteria (13 listed)
- Chronic active hepatitis/liver cirrhosis
- Severe heart disease (e.g., unstable angina, chronic congestive heart failure, use of antiarrhythmic agents)
- Ongoing gastric ulcer
- Acute bronchitis or pneumonia within one month
- Known reaction to lidocaine, albuterol sulfate, midazolam hydrochloride, and/or alfentanil hydrochloride
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 |
|---|---|---|
| defined green tea catechin extractGiven orally | Drug | Arm I |
| placeboGiven orally | Other | Arm II |
Primary outcome
Changes in oncogene/tumor suppression gene expression (part 1; completed March 22, 2006)
Time frame: 36 months
Phase I and II enzyme regulation by Affymetrix chip analysis in bronchial brush cells (part 1)
Time frame: 60 months
C-reactive protein level in plasma before treatment and 1 and 2 months after treatment (part 1)
Time frame: 60 months
Quantitative sputum score by image analysis before and 6 months after treatment (part 2)
Time frame: 36 months
9 secondary outcomes
Change in pathology grade of bronchial biopsies (part 2)
Time frame: 36 months
Morphometric index of bronchial biopsies and bronchoalveolar lavage cells (BAL) (part 2)
Time frame: 36 months
Methylation markers in sputa and BAL cells (part 2)
Time frame: 60 months
Ki-67 expression (part 2)
Time frame: 60 months
Cleaved caspase 3, p53, and VEGF assays in bronchial biopsies (part 2)
Time frame: 60 months
Oncogene and tumor suppression gene expression (part 2)
Time frame: 60 months
Phase I and II enzyme regulation by Affymetrix chip analysis of RNA from bronchial brush cells (part 2)
Time frame: 60 months
C-reactive protein levels in plasma before treatment, and 6 months after treatment (part 2)
Time frame: 36 months
Resolution or progression of non-calcified lung nodules on spiral CT (part 2)
Time frame: 60 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2012.
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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.
Stephen Lam, MD study chair
British Columbia Cancer Agency
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing defined green tea catechin extract in people with Lung Cancer and Tobacco Use Disorder, run by British Columbia Cancer Agency at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. 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 9 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in oncogene/tumor suppression gene expression (part 1; completed March 22, 2006) (time frame: 36 months). The study lists 4 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 9 Mar 2012.