Pioglitazone for Lung Cancer Chemoprevention
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ClinicalTrials.gov Identifier: NCT00780234 |
Recruitment Status
:
Active, not recruiting
First Posted
: October 27, 2008
Last Update Posted
: October 3, 2016
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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 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 391 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 |
Study Start Date : | August 2009 |
Actual Primary Completion Date : | June 2016 |
Estimated Study Completion Date : | August 2017 |

Arm | Intervention/treatment |
---|---|
Experimental: Arm 1: pioglitazone
Current or former smokers receive 6 months of treatment with pioglitazone
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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
|
- Changes in endobronchial histology [ Time Frame: 6 months ]

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

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
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 |
Principal Investigator: | Robert L. Keith, MD | VA Eastern Colorado Health Care System, Denver, CO |
Additional Information:
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 |
Last Update Posted: | October 3, 2016 |
Last Verified: | September 2016 |
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:
Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms |
Lung Diseases Respiratory Tract Diseases Pioglitazone Hypoglycemic Agents Physiological Effects of Drugs |