A Feasibility Study of Armodafinil for Brain Radiation-Induced Fatigue
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.
Interventional
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
Estimate accrual, adherence, retention, and participation of primary brain tumor patients undergoing partial or whole-brain RT who are randomized to receive armodafinil.
PRIMARY To estimate accrual, adherence, retention, and participation of primary brain tumor patients undergoing partial- or whole-brain RT who are randomized to receive armodafinil (150mg/daily), a CNS stimulant, or placebo. To estimate the variability of fatigue, quality of life, and neurocognitive function in this patient population.
9 - 11 Weeks
No
Edward G. Shaw, MD
Principal Investigator
Comprehensive Cancer Center of Wake Forest University
United States: Federal Government
CCCWFU97509
NCT01032200
August 2010
October 2012
Name | Location |
---|---|
Wake Forest University Comprehensive Cancer Center | Winston-Salem, North Carolina 27157-1096 |