Pioglitazone for Lung Cancer Chemoprevention
Condition: Lung Cancer; Endobronchial Dysplasia
MeSH terms: Lung Neoplasms
Intervention: fluorescence bronchoscopy; quantitative high resolution CT scan; PIOGLITAZONE VS. PLACEBO 30 mg
Intervention description: examination of the central airways with a bronchoscope. Both white light and fluorescent light will be used.; High resolution CT scan of the chest; 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 MeSH terms: Pioglitazone
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 92.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: chemoprevention; lung cancer; pioglitazone

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.
    

Eligibility 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