Clinical Trials

A Phase IIB Study of Pioglitazone for Oral Precancers

Protocol
09-163
Full Title
Phase IIB Randomized, Placebo Controlled Trial of Pioglitazone for Oral Premalignant Lesions: An Inter-Consortium Collaborative Study
Purpose

Pioglitazone (Actos®) is a drug used to treat type II diabetes. It also has the potential to reduce the risk of oral precancerous lesions from progressing to cancer.

In this study, researchers want to determine the effects of pioglitazone on oral precancers and the risk of developing oral cancer. Patients will be randomly assigned to receive pioglitazone or a placebo. Pioglitazone is a capsule that is taken orally.

Investigator
Jay O. Boyle, MD -- Director, Fellowship Training Program in Head and Neck Surgery
Jay O. Boyle - Physician Profile
Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have oral precancerous lesions at least 8mm in length and 3mm in width.
  • Patients must discontinue use of daily vitamin supplements at least 12 weeks before entering the study.
  • Patients may not already be receiving diabetes medications.
  • Patients must be age 18 or older.

For more information about this study and to inquire about eligibility, please contact Dr. Jay Boyle at 212-639-2906.

Disease(s)
Head & Neck Cancer: Oral Precancer
Locations
Related Diseases