Clinical trial · Interventional
ACAPHA in Preventing Lung Cancer in Former Smokers With Bronchial Intraepithelial Neoplasia
A Phase II Trial of ACAPHA in Former Smokers With Intraepithelial Neoplasia
NCT00522197CI-TRIAL-00006424completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Precancerous Condition | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| multi-herbal agent ACAPHA | Dietary Supplement | — | UNRESOLVED |
| Sugar Pill | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- ACAPHA
- interventionNames
- Dietary Supplement: multi-herbal agent ACAPHA
- type
- PLACEBO_COMPARATOR
- label
- Sugar Pill
- interventionNames
- Dietary Supplement: Sugar Pill
Primary outcomes (1)
- measure
- Efficacy and safety of multi-herbal agent ACAPHA as measured by combined histopathology and nuclear morphometry of intraepithelial neoplasia lesions
- timeFrame
- 12 months
Secondary outcomes (6)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 45 Years
- Maximum age
- 74 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.