Pioglitazone Hydrochloride in Preventing Radiation-Induced Cognitive Dysfunction in Treating Patients With Brain Tumors
|ClinicalTrials.gov Identifier: NCT01151670|
Recruitment Status : Completed
First Posted : June 28, 2010
Last Update Posted : May 30, 2017
RATIONALE: Pioglitazone hydrochloride may be effective treatment for cognitive dysfunction caused by radiation therapy.
PURPOSE: This phase I trial is studying the side effects and best dose of pioglitazone hydrochloride in preventing radiation-induced cognitive dysfunction in treating patients with brain tumors.
|Condition or disease||Intervention/treatment||Phase|
|Brain Neoplasms, Malignant Brain Neoplasms, Benign Malignant Meningioma Glioblastoma Multiforme Anaplastic Astrocytoma||Drug: pioglitazone Drug: Pioglitazone||Phase 1|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Use of Pioglitazone for the Prevention of Radiation-Induced Cognitive Dysfunction|
|Study Start Date :||August 2010|
|Primary Completion Date :||August 2014|
|Study Completion Date :||August 2014|
Experimental: Arm I
Pioglitazone 22.5 mg once daily by mouth
Pioglitazone 22.5 mg daily before, during and after radiation therapy.
Other Name: Actos
Experimental: Arm 2
Pioglitazone 45 mg once daily by mouth
Pioglitazone 45 mg by mouth daily before, during and after radiation therapy
Other Name: Actos
- Best tolerated dose of 2 different doses of orally administered pioglitazone [ Time Frame: From first dose to 1 day after last dose of drug ]
- Toxicities associated with both dose levels [ Time Frame: From first dose to 1 day after last dose of drug ]
- 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. [ Time Frame: From first dose to 1 day after last dose of drug ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01151670
|United States, North Carolina|
|Wake Forest University Health Sciences|
|Winston-Salem, North Carolina, United States, 27157|
|Principal Investigator:||Michael Chan||Wake Forest University Health Sciences|