Umphrey 2013.

Trial name or title	Armodafinil in Reducing Cancer‐Related Fatigue in Patients with High Grade Glioma
Methods	Phase III double‐blind placebo‐controlled randomised controlled trial. Participants were randomly assigned to receive one of two doses of armodafinil or placebo for 8 weeks
Participants	Inclusion criteria: aged ≥ 18 years; glioblastoma multiforme, anaplastic astrocytoma, gliosarcoma or anaplastic oligodendroglioma; clinically stable (stable/improved Karnofsky Performance Status compared to the prior month); completed radiotherapy > 21 days and ≤ 24 months prior to enrolment; ≥ 6 score on the worst fatigue question of the Brief Fatigue Inventory; previous surgery (gross total or sub‐total resection) or biopsy; negative serum pregnancy test done ≤ 7 days prior to registration; ability to complete questionnaire(s) by themselves or with assistance, Eastern Cooperative Oncology Group Performance Status 0, 1, 2 or 3; provide informed written consent; willing to return to enrolling institution for follow‐up (during the active monitoring phase of the study); stable dose of corticosteroid ≤ 28 days prior to registration Exclusion criteria: history of hypersensitivity to other psychostimulants; history of steroid psychosis; history of/currently taking medications for attention deficit hyperactivity disorder, severe anxiety disorder, schizophrenia or substance abuse by patient record or self report, or both; currently taking medications to treat fatigue including psychostimulants, antidepressants, acupuncture (antidepressants used to treat items other than fatigue (such as hot flushes or depression) were allowed if the person had been on a stable dose for ≥ 30 days and planned to continue for the duration of the trial); anticipating surgery; laboratory evidence of hypothyroidism with an elevated thyroid‐stimulating hormone concentration in the blood > 5.0 mlU/L; profound anaemia (haemoglobin < 10 g/dL) ≤ 28 days prior to registration; clinical depression per physician discretion; active/history of Tourette's syndrome or tic disorder, glaucoma, intractable epilepsy or uncontrolled seizure disorder; history of myocardial infarction, unstable angina, left ventricular hypertrophy or mitral valve prolapse syndrome; use of strong or moderate inhibitors of cytochrome P450 3A4 ≤ 7 days prior to registration; use of medications or substances that are inducers of cytochrome P450 3A4 ≤ 7 days prior to registration Follow‐up: 8 weeks Setting: 92 centres in the USA
Interventions	Arm 1: armodafinil 150 mg Arm 2: armodafinil 250 mg Arm 3: matched placebo
Outcomes	Participant‐reported fatigue (Brief Fatigue Inventory) Patient‐Reported Outcomes Measurement Information System Patient‐Reported Outcomes version of the Common Terminology Criteria for Adverse Events Cognitive functioning (Symbol Digit Modalities Test, Controlled Oral Word Association, Trail Making Test, Functional Assessment of Cancer Therapy ‐ Cognitive Function) Quality of life (linear analogue self assessment)
Starting date	2013
Contact information	Study Chair: Alyx Umphrey Mayo Clinic Rochester Minnesota MN 55905 USA +1 507 538 7623
Notes	ClinicalTrials.gov Identifier: NCT01781468 Current status: recruiting participants as of November 2015

IU: international units.