Lung CancerPhase 2NCT00522197
ACAPHA in Preventing Lung Cancer in Former Smokers With Bronchial Intraepithelial Neoplasia
A Phase 2 study testing multi-herbal agent ACAPHA and Sugar Pill in people with Lung Cancer and Precancerous Condition, run by British Columbia Cancer Agency.
Trial summary
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use of ACAPHA, a combination of six herbs, may prevent lung cancer from forming in former smokers with bronchial intraepithelial neoplasia. Read more about this study
- Who is it for?
- Ages 45 to 74 years
- Conditions the study is for
- Lung Cancer, Precancerous Condition
- What is being tested?
- multi-herbal agent ACAPHA and Sugar Pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Sep 2002to Nov 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
DISEASE CHARACTERISTICS:
- One or more areas of bronchial intraepithelial neoplasia (IEN) (metaplasia/dysplasia) with a nuclear morphometry index > 1.36 and a surface diameter > 1.2 mm on autofluorescence bronchoscopy
- Atypical sputum cells as determined by computer-assisted image analysis
- Former smoker (i.e., stopped smoking at least 1 year ago) who has smoked at least 30 pack-years (i.e., 1 pack/day for 30 years or more)
- Exhaled carbon monoxide level < 5 ppm
- No invasive cancer on bronchoscopy or abnormal spiral chest CT scan suspicious of lung cancer
PATIENT CHARACTERISTICS:
- ECOG performance status 0 or 1
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Normal renal function tests (BUN, creatinine, urinalysis)
- Normal liver function tests (AST, ALT, bilirubin, alkaline phosphatase)
- No chronic active hepatitis or liver cirrhosis
- No acute bronchitis or pneumonia within the past month
- No known reaction to xylocaine
- No medical condition that, in the opinion of the investigator, could jeopardize the patient's safety during participation in the study, including any of the following:
- Acute or chronic respiratory failure
- Unstable angina
- Uncontrolled congestive heart failure
- Bleeding disorder
PRIOR CONCURRENT THERAPY:
- Not specified
About this study
Official title: A Phase II Trial of ACAPHA in Former Smokers With Intraepithelial Neoplasia
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use of ACAPHA, a combination of six herbs, may prevent lung cancer from forming in former smokers with bronchial intraepithelial neoplasia.
PURPOSE: This randomized phase II trial is studying the side effects and how well ACAPHA works in preventing lung cancer in former smokers with bronchial intraepithelial neoplasia.
Read the detailed description
OBJECTIVES:
- Determine the efficacy and safety of multi-herbal agent ACAPHA in former smokers with bronchial intraepithelial neoplasia.
- Evaluate whether ACAPHA can modulate other surrogate endpoint biomarkers of aberrant methylation, cell cycle regulation, apoptosis, as well as phase I and II enzyme regulation.
- Establish a library of in vivo confocal microendoscopy images with corresponding histopathology, nuclear morphometry, and other biomarker information to assess the potential of confocal microendoscopy as a nonbiopsy method in assessing the effect of chemoprevention agents.
OUTLINE: Patients are stratified according to gender. Patients are randomized to 1 of 2 arms.
- Arm I: Patients receive oral multi-herbal agent ACAPHA twice daily for 6 months. Patients achieving a partial response receive an additional 6 months of ACAPHA.
- Arm II: Patients receive oral placebo twice daily for 6 months. Patients achieving a partial response receive an additional 6 months of placebo. Patients with progressive disease receive ACAPHA twice daily for 6 months.
Patients undergo sputum cytology, oral and bronchial brushings, bronchoalveolar lavage, and bronchial tissue biopsies at baseline and at 6 and 12 months. Samples are analyzed for histopathological and morphometric cell changes; MIB-1 bcl-2, and TUNEL immunostaining; methylation biomarkers; and gene expression analysis of RNA.
After completion of study therapy, patients are followed at 1 and 6 months.
- Conditions
- Lung Cancer, Precancerous Condition
- Being tested
- multi-herbal agent ACAPHA, Sugar Pill
- Keywords
- non-small cell lung cancer, small cell lung cancer, squamous lung dysplasia
- Medical subject headings
- Lung Neoplasms, Precancerous Conditions, 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.
multi-herbal agent ACAPHADietary supplement
Sugar PillDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| ACAPHA | Active comparator | Not described Receives: Dietary Supplement: multi-herbal agent ACAPHA |
| Sugar Pill | Placebo comparator | Not described Receives: Dietary Supplement: Sugar Pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy and safety of multi-herbal agent ACAPHA as measured by combined histopathology and nuclear morphometry of intraepithelial neoplasia lesions
Measured: 12 months
Secondary outcomes (6)
Changes in the severity of dysplasia by bronchial biopsy
Measured: 6 months
Changes in the morphometric index of sputum cells, bronchial biopsies, and epithelial cells in the bronchoalveolar lavage fluid (BAL)
Measured: 12 months
MIB-1, bcl-2, and TUNEL immunostaining in the bronchial biopsies
Measured: 12 months
Methylation biomarkers in the sputa, oral brush, and BAL cells
Measured: 12 months
Gene expression analysis of RNA from bronchial brush cells
Measured: 12 months
Volumetric measurement of CT scan-detected lung nodules before and after treatment
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2007 (estimated)
- Study startSep 2002
- Primary completionOct 2008
- Study completionNov 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- British Columbia Cancer Agency
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Stephen Lam, MD, Principal investigator, British Columbia Cancer Agency
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00522197
- Sponsor's protocol ID
- CDR0000562055
- Other IDs
- U01CA096109, BCCA-H02-61177-A002, BCCA-R02-1177
- Status last verified
- Mar 2012
- First submitted
- 28 Aug 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
- A Phase II Trial of ACAPHA in Former Smokers With Intraepithelial Neoplasia
- ClinicalTrials.gov ID
- NCT00522197
- Acronym / sponsor ID
- CDR0000562055
- Conditions
- Lung Cancer, Precancerous Condition
- Keywords
- non-small cell lung cancer, small cell lung cancer, squamous lung dysplasia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- British Columbia Cancer AgencyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2002
- Primary completion
- Oct 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 29 Aug 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. The use of ACAPHA, a combination of six herbs, may prevent lung cancer from forming in former smokers with bronchial intraepithelial neoplasia.
PURPOSE: This randomized phase II trial is studying the side effects and how well ACAPHA works in preventing lung cancer in former smokers with bronchial intraepithelial neoplasia.
Detailed description
OBJECTIVES:
- Determine the efficacy and safety of multi-herbal agent ACAPHA in former smokers with bronchial intraepithelial neoplasia.
- Evaluate whether ACAPHA can modulate other surrogate endpoint biomarkers of aberrant methylation, cell cycle regulation, apoptosis, as well as phase I and II enzyme regulation.
- Establish a library of in vivo confocal microendoscopy images with corresponding histopathology, nuclear morphometry, and other biomarker information to assess the potential of confocal microendoscopy as a nonbiopsy method in assessing the effect of chemoprevention agents.
OUTLINE: Patients are stratified according to gender. Patients are randomized to 1 of 2 arms.
- Arm I: Patients receive oral multi-herbal agent ACAPHA twice daily for 6 months. Patients achieving a partial response receive an additional 6 months of ACAPHA.
- Arm II: Patients receive oral placebo twice daily for 6 months. Patients achieving a partial response receive an additional 6 months of placebo. Patients with progressive disease receive ACAPHA twice daily for 6 months.
Patients undergo sputum cytology, oral and bronchial brushings, bronchoalveolar lavage, and bronchial tissue biopsies at baseline and at 6 and 12 months. Samples are analyzed for histopathological and morphometric cell changes; MIB-1 bcl-2, and TUNEL immunostaining; methylation biomarkers; and gene expression analysis of RNA.
After completion of study therapy, patients are followed at 1 and 6 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACAPHA | Active comparator | Dietary Supplement: multi-herbal agent ACAPHA |
| Sugar Pill | Placebo comparator | Dietary Supplement: Sugar Pill |
Who may qualify
- Ages
- 45 to 74 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 |
|---|---|---|
| multi-herbal agent ACAPHA | Dietary supplement | ACAPHA |
| Sugar Pill | Dietary supplement | Sugar Pill |
Primary outcome
Efficacy and safety of multi-herbal agent ACAPHA as measured by combined histopathology and nuclear morphometry of intraepithelial neoplasia lesions
Time frame: 12 months
6 secondary outcomes
Changes in the severity of dysplasia by bronchial biopsy
Time frame: 6 months
Changes in the morphometric index of sputum cells, bronchial biopsies, and epithelial cells in the bronchoalveolar lavage fluid (BAL)
Time frame: 12 months
MIB-1, bcl-2, and TUNEL immunostaining in the bronchial biopsies
Time frame: 12 months
Methylation biomarkers in the sputa, oral brush, and BAL cells
Time frame: 12 months
Gene expression analysis of RNA from bronchial brush cells
Time frame: 12 months
Volumetric measurement of CT scan-detected lung nodules before and after treatment
Time frame: 12 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 principal investigator
British Columbia Cancer Agency
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing multi-herbal agent ACAPHA and Sugar Pill in people with Lung Cancer and Precancerous Condition, run by British Columbia Cancer Agency.
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 9 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
Efficacy and safety of multi-herbal agent ACAPHA as measured by combined histopathology and nuclear morphometry of intraepithelial neoplasia lesions (time frame: 12 months). 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.