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. 2014 Dec 18;2014(12):CD011335. doi: 10.1002/14651858.CD011335.pub2

Shaw 2013

Methods Phase II double‐blind placebo‐controlled RCT. Patients were randomly assigned to receive armodafinil or a placebo during cranial irradiation and for four weeks following RT. Patients completed assessments at baseline, at the end of RT, and 4 weeks after the end of RT. Intervention toxicity was recorded.
Participants Patients with a primary brain tumour receiving a total RT dose of 45 Gy during participation.
Interventions Arm I: 150 mg/day Armodafinil
Arm II: Placebo
Outcomes Fatigue (BFI, FACIT‐Fatigue)
Sleepiness (ESS)
Quality of life (FACT, FACT‐brain)
Cognitive function (Wake Forest Cognitive Function Battery)
Notes In the armodafinil treatment arm, fatigue, sleepiness and quality of life scores significantly improved at the end of RT, compared with the placebo arm.

Scales BFI Brief Fatigue Inventory;FACIT‐Fatigue Functional Assessment of Chronic Illness Therapy ‐ Fatigue; ESS Epworth Sleepiness Scale; FACT Functional Assessment of Cancer Therapy