Major Program
Cancer Prevention Clinical Trials Network
Research Group
Lung and Upper Aerodigestive Cancer
Sponsor
National Cancer Institute (NCI)
Status
Recruiting
ClinicalTrials.gov ID
For more information, see ClinicalTrials.gov NCT05237960
This phase IIb trial tests whether metformin works in preventing oral cancer in patients with
oral leukoplakia (white patches) or erythroplakia (red patches). Metformin is in a class of
drugs called biguanides. Metformin helps to control the amount of glucose (sugar) in the
blood. It decreases the amount of glucose patients absorb from food and the amount of glucose
made by the liver. Metformin also increases the body's response to insulin, a natural
substance that controls the amount of glucose in the blood. This trial may help researchers
determine if metformin can stop changes in the mouth that are related to pre-cancer growths
in the mouth.
oral leukoplakia (white patches) or erythroplakia (red patches). Metformin is in a class of
drugs called biguanides. Metformin helps to control the amount of glucose (sugar) in the
blood. It decreases the amount of glucose patients absorb from food and the amount of glucose
made by the liver. Metformin also increases the body's response to insulin, a natural
substance that controls the amount of glucose in the blood. This trial may help researchers
determine if metformin can stop changes in the mouth that are related to pre-cancer growths
in the mouth.
Intervention
Biopsy, Biospecimen Collection, Extended Release Metformin Hydrochloride, Placebo Administration
Condition
Erythroplakia, Oral Leukoplakia
Investigators
Scott M Lippman, Shethal Bearelly, Scott M. Lippman, Christine H. Chung, Jennifer Gross, Cherie-Ann O. Nathan, Justine Moe, Frank G. Ondrey, Alexander R. Kerr, Miriam Rosin, Leigha Rock