Pioglitazone for Lung Cancer Chemoprevention

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2017-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Lung Cancer Endobronchial Dysplasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Arm 1: pioglitazone

Current or former smokers receive 6 months of treatment with pioglitazone

Group Type EXPERIMENTAL

fluorescence bronchoscopy

Intervention Type PROCEDURE

examination of the central airways with a bronchoscope. Both white light and fluorescent light will be used.

quantitative high resolution CT scan

Intervention Type PROCEDURE

High resolution CT scan of the chest

PIOGLITAZONE VS. PLACEBO 30 mg

Intervention Type DRUG

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.

Arm 2: placebo

Current or former smokers receive 6 months of treatment with placebo

Group Type PLACEBO_COMPARATOR

fluorescence bronchoscopy

Intervention Type PROCEDURE

examination of the central airways with a bronchoscope. Both white light and fluorescent light will be used.

quantitative high resolution CT scan

Intervention Type PROCEDURE

High resolution CT scan of the chest

Interventions

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fluorescence bronchoscopy

examination of the central airways with a bronchoscope. Both white light and fluorescent light will be used.

Intervention Type PROCEDURE

quantitative high resolution CT scan

High resolution CT scan of the chest

Intervention Type PROCEDURE

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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No