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 range

45 Years – 74 Years

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Efficacy and safety of multi-herbal agent ACAPHA as measured by combined histopathology and nuclear morphometry of intraepithelial neoplasia lesions

Timeframe: 12 months

Trial details

NCT IDNCT00522197

SponsorBritish Columbia Cancer Agency

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2008-10

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