---
title: ACAPHA in Preventing Lung Cancer in Former Smokers With Bronchial Intraepithelial Neoplasia
nct_id: NCT00522197
overall_status: COMPLETED
phase: PHASE2
sponsor: British Columbia Cancer Agency
study_type: INTERVENTIONAL
primary_condition: Lung Cancer
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00522197.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00522197"
ct_last_update_post_date: 2012-03-09
last_seen_at: "2026-05-12T06:06:52.885Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# ACAPHA in Preventing Lung Cancer in Former Smokers With Bronchial Intraepithelial Neoplasia

**Official Title:** A Phase II Trial of ACAPHA in Former Smokers With Intraepithelial Neoplasia

**NCT ID:** [NCT00522197](https://clinicaltrials.gov/study/NCT00522197)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 90
- **Lead Sponsor:** British Columbia Cancer Agency
- **Collaborators:** National Cancer Institute (NCI)
- **Conditions:** Lung Cancer, Precancerous Condition
- **Start Date:** 2002-09
- **Completion Date:** 2008-11
- **CT.gov Last Update:** 2012-03-09

## Brief 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.

## 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.

## Eligibility

- **Minimum age:** 45 Years
- **Maximum age:** 74 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **ACAPHA** (ACTIVE_COMPARATOR)
- **Sugar Pill** (PLACEBO_COMPARATOR)

## Interventions

- **multi-herbal agent ACAPHA** (DIETARY_SUPPLEMENT)
- **Sugar Pill** (DIETARY_SUPPLEMENT)

## Primary Outcomes

- **Efficacy and safety of multi-herbal agent ACAPHA as measured by combined histopathology and nuclear morphometry of intraepithelial neoplasia lesions** _(time frame: 12 months)_

## 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)_

## Recent Field Changes (last 30 days)

- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00522197.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00522197*  
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