Use of Pioglitazone for the Prevention of Radiation-Induced Cognitive Dysfunction
PRIMARY OBJECTIVE:
I. To evaluate the tolerability and toxicity associated with two different dose regimens of
pioglitazone administered orally as a cytoprotective agent against radiation-induced brain
injury.
SECONDARY OBJECTIVE:
I. To evaluate the effect of pioglitazone on glycemic levels and hemoglobin A1c values when
pioglitazone is used as a cytoprotective agent concurrent with radiotherapy in normoglycemic
patients.
OUTLINE: Patients undergo fractionated external beam radiotherapy, 3-D conformal
radiotherapy, or intensity-modulated radiotherapy. Patients receive oral pioglitazone
hydrochloride once daily before for 1 week prior to brain irradiation, during and and
continuing for 6 months after completion of radiation radiotherapy. After completion of
study treatment, patients are followed periodically.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Best tolerated dose of 2 different doses of orally administered pioglitazone
From first dose to 1 day after last dose of drug
Yes
Michael Chan
Principal Investigator
Wake Forest University
United States: Institutional Review Board
CCCWFU 97409
NCT01151670
August 2010
August 2013
Name | Location |
---|---|
Wake Forest University Health Sciences | Winston-Salem, North Carolina 27157 |