NCT00522197

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P75+ for phase_2 lung-cancer

Timeline
Completed

Started Sep 2002

Typical duration for phase_2 lung-cancer

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2002

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

August 28, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 29, 2007

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

March 9, 2012

Status Verified

March 1, 2012

Enrollment Period

6.1 years

First QC Date

August 28, 2007

Last Update Submit

March 7, 2012

Conditions

Lung CancerPrecancerous Condition

Keywords

non-small cell lung cancersmall cell lung cancersquamous lung dysplasia

Outcome Measures

Primary Outcomes (1)

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

    12 months

Secondary Outcomes (6)

  • Changes in the severity of dysplasia by bronchial biopsy

    6 months

  • Changes in the morphometric index of sputum cells, bronchial biopsies, and epithelial cells in the bronchoalveolar lavage fluid (BAL)

    12 months

  • MIB-1, bcl-2, and TUNEL immunostaining in the bronchial biopsies

    12 months

  • Methylation biomarkers in the sputa, oral brush, and BAL cells

    12 months

  • Gene expression analysis of RNA from bronchial brush cells

    12 months

  • +1 more secondary outcomes

Study Arms (2)

ACAPHA

ACTIVE COMPARATOR
Dietary Supplement: multi-herbal agent ACAPHA

Sugar Pill

PLACEBO COMPARATOR
Dietary Supplement: Sugar Pill

Interventions

multi-herbal agent ACAPHADIETARY_SUPPLEMENT
ACAPHA
Sugar PillDIETARY_SUPPLEMENT
Sugar Pill

Eligibility Criteria

Age45 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Lung NeoplasmsPrecancerous ConditionsCarcinoma, Non-Small-Cell LungSmall Cell Lung Carcinoma

Interventions

antitumor ASugars

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Intervention Hierarchy (Ancestors)

Carbohydrates

Study Officials

  • Stephen Lam, MD

    British Columbia Cancer Agency

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2007

First Posted

August 29, 2007

Study Start

September 1, 2002

Primary Completion

October 1, 2008

Study Completion

November 1, 2008

Last Updated

March 9, 2012

Record last verified: 2012-03