NCT01032200

Armodafinil in Treating Fatigue Caused By Radiation Therapy in Patients With Primary Brain Tumors

A Feasibility Study of Armodafinil for Brain Radiation-Induced Fatigue

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Brain Tumors
• Nervous System Tumors
• Cognition Disorders
• Fatigue

Interventions

Type	Name	Description
DRUG	Armodafinil	Given orally
OTHER	placebo	Given orally

Timeline

• Start date: 2010-08-01
• Primary completion: 2013-01-08
• Completion: 2013-01-08
• First posted: 2009-12-15
• Last updated: 2021-09-28
• Results posted: 2017-02-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study