ACAPHA in Preventing Lung Cancer in Former Smokers With Bronchial Intraepithelial Neoplasia
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|ClinicalTrials.gov Identifier: NCT00522197|
Recruitment Status : Completed
First Posted : August 29, 2007
Last Update Posted : March 9, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer Precancerous Condition||Dietary Supplement: multi-herbal agent ACAPHA Dietary Supplement: Sugar Pill||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||90 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Phase II Trial of ACAPHA in Former Smokers With Intraepithelial Neoplasia|
|Study Start Date :||September 2002|
|Actual Primary Completion Date :||October 2008|
|Actual Study Completion Date :||November 2008|
|Active Comparator: ACAPHA||Dietary Supplement: multi-herbal agent ACAPHA|
|Placebo Comparator: Sugar Pill||Dietary Supplement: Sugar Pill|
- Efficacy and safety of multi-herbal agent ACAPHA as measured by combined histopathology and nuclear morphometry of intraepithelial neoplasia lesions [ Time Frame: 12 months ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00522197
|Principal Investigator:||Stephen Lam, MD||British Columbia Cancer Agency|