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Pioglitazone for Lung Cancer Chemoprevention

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ClinicalTrials.gov Identifier: NCT00780234
Recruitment Status : Completed
First Posted : October 27, 2008
Results First Posted : April 11, 2019
Last Update Posted : April 11, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
This is a chemoprevention trial evaluating the diabetic agent pioglitazone. Non-diabetic subjects at risk for lung cancer (based on smoking history, lung function testing, and atypical cells in a sputum sample) receive either placebo or pioglitazone and have chest computerized tomography (CAT) scans and examinations of their airways with a bronchoscope at the start of the trial and after 6 months on treatment. Compensation will be provided to the subject after completing the trial.

Condition or disease Intervention/treatment Phase
Lung Cancer Endobronchial Dysplasia Procedure: fluorescence bronchoscopy Procedure: quantitative high resolution CT scan Drug: PIOGLITAZONE VS. PLACEBO 30 mg Phase 2

Detailed Description:
This trial evaluates the oral peroxisome proliferator-activated receptor gamma (PPARgamma) agonist pioglitazone in a double-blind placebo controlled trial. The high risk current and former smokers qualify based on tobacco exposure, airflow limitation on lung function testing, and sputum cytologic atypia. Subjects have a quantitative high resolution thoracic CT scan and a fluorescent bronchoscopy at study entry and after 6 months on drug or placebo. Biologic samples are collected at both time points. The primary outcome is endobronchial histology and determining if pioglitazone can retard progression. Secondary endpoints related to the PPAR gamma signaling pathway will also be analyzed.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Pioglitazone for Lung Cancer Chemoprevention
Actual Study Start Date : August 2009
Actual Primary Completion Date : June 2016
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Arm 1: pioglitazone
Current or former smokers receive 6 months of treatment with pioglitazone
Procedure: fluorescence bronchoscopy
examination of the central airways with a bronchoscope. Both white light and fluorescent light will be used.

Procedure: quantitative high resolution CT scan
High resolution CT scan of the chest

Drug: PIOGLITAZONE VS. PLACEBO 30 mg

Patients will be randomized to receive either pioglitazone or placebo. Pioglitazone hydrochloride, a thiazolidinedione antidiabetic agent and a potent peroxisome proliferator-

activated receptor-gamma agonist. It is FDA approved for the treatment of Type II diabetes. It has been previously administered to non-diabetic subjects. The most common side effect of pioglitazone is fluid retention and modest weight gain. There is a potential risk that pioglitazone may cause an elevation in liver enzymes and more serious hepatotoxicity (rare). There is risk of edema and weight gain associated with pioglitazone therapy. 5% experienced peripheral edema in clinical trials. fluid retention may result in new onset heart failure or exacerbation of existing heart failure. Small risk of hypoglycemia, anemia, myalgia, bone fracture, headache, and macular retinal edema exists. There is insufficient information to confirm its safety in Pregnancy/Breastfeeding. Bladder cancer is more serious but rare.


Placebo Comparator: Arm 2: placebo
Current or former smokers receive 6 months of treatment with placebo
Procedure: fluorescence bronchoscopy
examination of the central airways with a bronchoscope. Both white light and fluorescent light will be used.

Procedure: quantitative high resolution CT scan
High resolution CT scan of the chest




Primary Outcome Measures :
  1. 6-month Histology Score [ Time Frame: 6 months ]
    Biopsies were classified into one of the following 8 World Health Organization defined categories to classify the endobronchial lesion and assign a score according to the following scale: 1 = normal bronchial epithelium; 2 = reserve cell hyperplasia; 3 = squamous metaplasia without atypia; 4 = mild dysplasia; 5 = moderate dysplasia; 6 = severe dysplasia; 7 = carcinoma in situ (CIS); and 8 = invasive carcinoma. 1 represents the best outcome and 8 represents the worst outcome.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Current or former smoker (at least 10 pack years);
  • One or more of the following:
  • Mild or worse sputum atypia
  • Airflow Limitation (FEV1/FVC<70% predicted)
  • Biopsy proven airway dysplasia

Exclusion Criteria:

  • myocardial infarction (MI) with ejection fraction < 50%;
  • severe/unstable angina;
  • history of coronary or peripheral arterial bypass grafting;
  • New York Heart Association (NYHA) class III or IV congestive heart failure;
  • hypoxemia (less than POX 90 with supplemental oxygen); Diabetes type I or II; severe COPD (GOLD stage III or IV); clinically significant edema requiring diuretic therapy;
  • life expectancy < 6 months; history of bladder cancer
  • pregnant or breast feeding; inability to give informed consent

Information from the National Library of Medicine

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): NCT00780234


Locations
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United States, Colorado
VA Eastern Colorado Health Care System, Denver, CO
Denver, Colorado, United States, 80220
United States, Tennessee
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
Nashville, Tennessee, United States, 37212-2637
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Robert L. Keith, MD VA Eastern Colorado Health Care System, Denver, CO

Additional Information:
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00780234     History of Changes
Other Study ID Numbers: CLIN-005-08S
First Posted: October 27, 2008    Key Record Dates
Results First Posted: April 11, 2019
Last Update Posted: April 11, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by VA Office of Research and Development:
chemoprevention
lung cancer
pioglitazone
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Pioglitazone
Hypoglycemic Agents
Physiological Effects of Drugs