Kaleita 2006

Methods	Randomised controlled trial, parallel arm, double‐blind.
Participants	Inclusion criteria: aged 21‐65, primary brain tumour, receiving treatment in the UCLA Neuro‐Oncology Program, prior neurosurgical resection, radiotherapy, and/or cytotoxic or cytostatic chemotherapy, mild to severe fatigue and/or attention/memory impairment, as measured by the Clinical Global Impression of Severity Scale, able to speak English, capable of completing self‐rating scales and one‐on‐one psychometric tests, at least 30 days since prior stimulants (e.g., amphetamines or methylphenidate), negative pregnancy test and use of contraception if fertile, concurrent conventional chemotherapy (e.g., carboplatin, lomustine, temozolomide), glucocorticoids (e.g. dexamethasone) and tamoxifen allowed. Exclusion criteria: significant hepatic disease, significant renal disease, severe cognitive impairment, other terminal illness, emergency patient, institutional resident, prisoner or parolee, UCLA students or staff, pregnant or nursing, concurrent irinotecan, concurrent participation in UCLA experimental chemotherapy trials, prior modafinil, concurrent experimental anticancer medication, concurrent tricyclic antidepressants and/or monoamine oxidase inhibitors. No. randomised: 30 (each arm not reported). Follow‐up: 1, 3, 4, 8 and 12 weeks. Setting: one centre in the United states.
Interventions	Arm I: 200 mg/day modafinil in divided doses for 3 weeks Arm II: 400 mg/day modafinil in divided doses for 3 weeks Both arms then completed a 1‐week wash out period, followed up 200 mg/day modafinil for 3 days, followed by a titrated dose for 8 weeks.
Outcomes	Cognitive function (TMT, SDM, verbal fluency test) Fatigue (Fatigue severity scale, Visual analogue fatigue scale, modified fatigue impact scale) Mood (HDS)
Notes	All participants required to have mild or severe fatigue.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Use of a randomisation method reported but not described.
Allocation concealment (selection bias)	Low risk	Blinding carried out.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Blinding carried out.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Blinding carried out.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Projected accrual successful.
Selective reporting (reporting bias)	Low risk	All outcomes reported.
Other bias	Unclear risk	All participants required to have mild or severe fatigue.