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Pioglitazone Hydrochloride in Preventing Radiation-Induced Cognitive Dysfunction in Treating Patients With Brain Tumors

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ClinicalTrials.gov Identifier: NCT01151670
Recruitment Status : Completed
First Posted : June 28, 2010
Last Update Posted : August 1, 2018
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Brief Summary:

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

Detailed Description:


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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Non-Randomized
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
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Arm Intervention/treatment
Experimental: Arm I
Pioglitazone 22.5 mg once daily by mouth
Drug: pioglitazone
Pioglitazone 22.5 mg daily before, during and after radiation therapy.
Other Name: Actos

Experimental: Arm 2
Pioglitazone 45 mg once daily by mouth
Drug: Pioglitazone
Pioglitazone 45 mg by mouth daily before, during and after radiation therapy
Other Name: Actos

Primary Outcome Measures :
  1. Best tolerated dose of 2 different doses of orally administered pioglitazone [ Time Frame: From first dose to 1 day after last dose of drug ]

Secondary Outcome Measures :
  1. Toxicities associated with both dose levels [ Time Frame: From first dose to 1 day after last dose of drug ]
  2. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients must have histologically or cytologically confirmed brain tumors of the following types: Group 1: malignant brain tumors (glioblastoma multiforme, anaplastic gliomas, brain metastases, and other malignant brain tumors); or Group 2: low grade brain tumors (low grade gliomas, meningiomas, and other low grade brain tumors)
  • All stages and grades of brain tumors are eligible
  • Patients must have an ECOG performance status of 0-2
  • Patients must have agreed to be treated with fractionated, external beam radiation treatment (EBRT) with either curative or palliative intent (the length of the radiation course must at least be ten fractions)
  • Patients must have agreed to have CT and MR imaging for purposes of radiation treatment planning, radiation treatment monitoring, and/or radiation treatment evaluation
  • Patients must have measurable disease and/or relevant anatomic features using Magnetic Resonance Imaging
  • Prior therapies (cytotoxic, surgery, and radiation) are acceptable
  • Use of steroids is acceptable when indicated
  • Patients must be able to understand and willingly give informed written consent to participate
  • Women of childbearing potential must not be pregnant or nursing and must use medically appropriate contraception if sexually active
  • Patients must have a life expectancy of greater than 3 months
  • Patients must be willing to comply with an oral treatment regimen and be able to swallow oral study tablets

Exclusion Criteria:

  • History of allergic reactions to pioglitazone or any other member of the thiazolidinedione family
  • Current diagnosis of diabetes as defined by fasting blood sugar > 125, treatment with anti-diabetic medications, or history of diabetes
  • Patients who take insulin
  • Patients who have NYHA class III or IV heart failure
  • Patients who have elevated transaminases (AST or ALT > 2.5 times normal limit)
  • Patients who have significantly impaired renal function (creatinine >= 1.5)
  • Patients who are significantly anemic (hematocrit < 33% in men, or < 30% in women)
  • Patients who have symptomatic edema (>= grade 2)
  • Patients who are on medications that have been shown to have a drug interaction with pioglitazone: atorvastatin (doses > 80 mg/day), systemic anti-fungals, medications with significant CYP 3A4 inhibiting properties
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac, arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Pregnant women are excluded from this study if their pregnancy precludes radiation treatment because ionizing radiation used in radiation treatment is an agent with known potential for teratogenic or abortifacient effects
  • Patients with psychiatric or social illnesses that may impair compliance with the trial requirements

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01151670

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United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
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Principal Investigator: Michael Chan Wake Forest University Health Sciences
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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT01151670    
Obsolete Identifiers: NCT01586078
Other Study ID Numbers: IRB00014528
NCI-2009-01452 ( Registry Identifier: CTRP )
CCCWFU 97409 ( Other Identifier: Wake Forest University Health Sciences )
First Posted: June 28, 2010    Key Record Dates
Last Update Posted: August 1, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wake Forest University Health Sciences:
radiation therapy
cognitive dysfunction
brain tumor
memory problems
short term memory loss
Additional relevant MeSH terms:
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Brain Neoplasms
Cognitive Dysfunction
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Neoplasms, Vascular Tissue
Meningeal Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Nervous System Diseases
Brain Diseases
Central Nervous System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs