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