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 RCT. Patients are randomly assigned to receive one of two doses of armodafinil or a placebo for 8 weeks.
Participants	Inclusion criteria: aged ≥ 18yrs; glioblastoma multiforme, anaplastic astrocytoma, gliosarcoma, or anaplastic oligodendroglioma; clinically stable (stable/improved KPS compared to the prior month); completed radiation therapy > 21 days and ≤ 24 months prior to enrolment; ≥ 6 score on the worst fatigue question of the BFI (Brief Fatigue Inventory); previous surgery (gross total or subtotal resection) or biopsy; negative serum pregnancy test done ≤ 7 days prior to registration; ability to complete questionnaire(s) by themselves or with assistance, ECOG PS 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 and/or self‐report; currently taking medications to treat fatigue including psychostimulants, antidepressants, acupuncture (antidepressants used to treat items other than fatigue (such as hot flushes or depression) are allowed if the patient has been on a stable dose for ≥ 30 days and plans to continue for the duration of the trial); anticipating surgery; laboratory evidence of hypothyroidism with an elevated thyroid stimulating hormone (TSH) concentration in the blood > 5.0 mlU/L; profound anaemia (haemoglobin level of < 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 (CYP3A4) ≤ 7 days prior to registration; use of medications or substances that are inducers of CYP3A4 ≤ 7 days prior to registration. Follow‐up: 8 weeks Setting: 92 centres in the United States.
Interventions	Arm I: 150 mg Armodafinil Arm II: 250 mg Armodafinil Arm III: Placebo
Outcomes	Patient‐reported fatigue (BFI) Cognitive functioning (SDM, COWA, TMT, FACT‐Cog) Quality of life (LASA).
Starting date	2013
Contact information	Recruitment is being carried out in 92 centres. Study Chair: Alyx Umphrey Mayo Clinic Rochester Minnesota United States 55905 507‐538‐7623
Notes	ClinicalTrials.gov Identifier: NCT01781468 Current status: Recruiting participants.

Scales BFI Brief Fatigue Inventory; SDM Symbol Digit Modalities Test; COWA Controlled Oral Work Association Test; TMT Trail making test; FACT‐Cog Functional Assessment of Cancer Therapy‐Cognitive Function; LASA Linear Analogue Self Assessment