ACAPHA in Preventing Lung Cancer in Former Smokers With Bronchial Intraepithelial Neoplasia (NCT00522197) | Clinical Trial Compass
CompletedPhase 2
ACAPHA in Preventing Lung Cancer in Former Smokers With Bronchial Intraepithelial Neoplasia
90 participantsStarted 2002-09
Plain-language 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.
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.
Who can participate
Age range45 Years – 74 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Efficacy and safety of multi-herbal agent ACAPHA as measured by combined histopathology and nuclear morphometry of intraepithelial neoplasia lesions