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Are you A CURRENT or FORMER SMOKER?

I have liver cirrhosis: Welcome

Lung cancer, specifically non-small lung cancer (NSCLC), is the leading cause of cancer-related deaths and the second most common cancer in the United States. Former tobacco smokers are at 6-fold higher risk for lung cancer compared to non-smokers. Contrary to common belief, about 60% of individuals at high risk for lung cancer, or those diagnosed in early stages, are overweight (BMI ≥ 25). Ways to help protect high-risk individuals are needed. We are seeing if Metformin Extended Release (ER) has preventive and protective effects that can lower this risk.

ROLE OF METFORMIN IN PREVENTION OF LUNG CANCER IN HIGH-RISK OVERWEIGHT OR OBESE INDIVIDUALS

Principal Investigators: 
Sai Yendamuri, MD - Roswell Park Comprehensive Cancer Center
Robert L. Keith, MD - Rocky Mountain Regional VA Medical Center
Stephen Lam, MD - University of British Columbia, BC Cancer Research Centre 

Sean A. Jordan, MD, MHS, FACS - University of Tennessee, Knoxville

Metformin ER has been widely used in the US since 1995 and is FDA approved to treat Diabetes Mellitus. Participants who are former smokers will undergo a bronchoscopy, a medical procedure to look into your lungs, and will then be placed into one of two groups based on random chance. Group 1 will receive up to 2000 mg of metformin orally once daily for up to 26 weeks. Group 2 will wait 6 months, undergo another bronchoscopy, and then receive up to 2000 mg of Metformin ER orally once a day for 26 weeks. Participants who are current smokers (group 3) will undergo a bronchoscopy and will then receive up to 2000 mg of metformin orally once daily for up to 26 weeks. Participants in all groups will undergo a final bronchoscopy after finishing their study medication. (Note: people in group 2 will undergo 3 bronchoscopies). This will allow researchers to see if participants taking Metformin ER show changes in their lungs, which may indicate a lower risk of developing cancer. Reimbursement will be provided for your transportation, parking, and other study-related time and expenses.

 

You may be eligible if:

  • You are a current smoker or a former smoker who have quit smoking at least 12 months prior to enrollment.

  • You have a BMI greater than or equal to 25 with no prior diagnosis of Diabetes Mellitus (DM1 or DM2).

  • You have not used Metformin within the past 2 years.

 

If you think you may be eligible, you can contact the study team at your preferred location from the list below: 

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ROSWELL PARK COMPREHENSIVE CANCER CENTER Alexandra House: (716) 845-1300, ext. 783, Alexandra.House@RoswellPark.org - Buffalo, New York

ROCKY MOUNTAIN REGIONAL VA MEDICAL CENTER - Sarah Crawford: (303) 724-8300, sarah.crawford@cuanschutz.edu - Aurora, Colorado

UNIVERSITY OF BRITISH COLUMBIA, BC CANCER RESEARCH CENTRE Sukhinder Khattra: (604) 675-8089 skhattra@bccancer.bc.ca – Vancouver, Canada

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More Information: https://clinicaltrials.gov/ct2/show/study/NCT04931017

Additional Resources

Study Brochure

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