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Pioglitazone for Lung Cancer Chemoprevention

NCT00780234 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2019-04-11

Study results available
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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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Robert L. Keith, MD · VA Eastern Colorado Health Care System, Denver, CO

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2016-06-30
Completion
2017-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00780234 on ClinicalTrials.gov