Clinical trial NCT01032200
Conditions: Brain Tumors Nervous System Tumors Cognition Disorders Fatigue
Keywords: fatigue cognitive/functional effects adult giant cell glioblastoma adult glioblastoma adult gliosarcoma adult anaplastic astrocytoma adult anaplastic oligodendroglioma adult mixed glioma adult diffuse astrocytoma adult pilocytic astrocytoma adult pineal gland astrocytoma adult subependymal giant cell astrocytoma adult oligodendroglioma adult anaplastic ependymoma adult ependymoma adult myxopapillary ependymoma adult subependymoma adult anaplastic meningioma adult grade I meningioma adult grade II meningioma adult grade III meningioma adult papillary meningioma adult brain stem glioma
Sponsor: Wake Forest University Health Sciences
Start date: 2010-08-01; Completion date: 2013-01-08
Enrollment: 54 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
RATIONALE: Armodafinil may help relieve fatigue and improve quality of life in patients with cancer receiving radiation therapy to the brain.

PURPOSE: This clinical trial is studying how well armodafinil works in treating fatigue caused by radiation therapy in patients with primary brain tumors.

Detailed description:
OBJECTIVES:

Primary

* To estimate study accrual, adherence, retention, and participation of patients with primary brain tumors undergoing partial- or whole-brain radiotherapy who are randomized to receive armodafinil or placebo.
* To estimate the variability of fatigue, quality of life, and neurocognitive function in these patients.

Secondary

* To obtain a preliminary estimate of the effect of armodafinil on fatigue as measured by the fatigue subscale of the FACIT-F and the Brief Fatigue Inventory.
* To estimate the rates of toxicity and adverse events associated with armodafinil.
* To obtain preliminary estimates of the effect of armodafinil on sleepiness as measured by the Epworth Sleep Scale; overall quality of life and brain-specific quality of life as measured by the FACT-G with the brain subscale; and cognitive function as measured by a comprehensive Wake Forest Cognitive Function Battery.

OUTLINE: This is a multicenter study. Patients are stratified according to therapy (radiotherapy alone vs radiotherapy and chemotherapy) and Karnofsky performance status (60-80% vs 90-100%). Patients are randomized to 1 of 2 arms.

* Arm I: Patients receive oral armodafinil once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.
* Arm II: Patients receive oral placebo once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.

Patients complete questionnaires assessing fatigue, quality of life, and neurocognitive function at baseline and periodically during study.

Arms: arm 1: Patients receive oral armodafinil once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity. arm 2: Patients receive oral placebo once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.
Interventions: intervention 1: Armodafinil intervention 2: placebo
Intervention descriptions: intervention 1: Given orally intervention 2: Given orally

Protocol documents: