Trial reportNeuro-oncology2013
The effect of modafinil on fatigue, cognitive functioning, and mood in primary brain tumor patients: a multicenter randomized controlled trial.
Trial report in Neuro-oncology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 66 papers, 9 of them syntheses that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
66 citing papers in PubMed, 9 syntheses or guidelines pooled it, 130 citations in OpenAlex.
- Efficacy of traditional Chinese medicine external therapy on cancer-related fatigue: a systematic review and network meta-analysis.Frontiers in oncology · 2026Pooled it
- A systematic review of cognitive interventions for adult patients with brain tumours.Cancer medicine · 2023Pooled it
- Interventions for preventing and ameliorating cognitive deficits in adults treated with cranial irradiation.The Cochrane database of systematic reviews · 2022Pooled it
- Interventions for the management of fatigue in adults with a primary brain tumour.The Cochrane database of systematic reviews · 2022Pooled it
- Placebo response in trials of drug treatments for cancer-related fatigue: a systematic review, meta-analysis and meta-regression.BMJ supportive & palliative care · 2020Pooled it
- Pharmacological treatment of depression in people with a primary brain tumour.The Cochrane database of systematic reviews · 2020Pooled it
- Interventions for the management of fatigue in adults with a primary brain tumour.The Cochrane database of systematic reviews · 2016Pooled it
- Interventions for preventing and ameliorating cognitive deficits in adults treated with cranial irradiation.The Cochrane database of systematic reviews · 2014Pooled it
- Pharmacological Interventions for the Management of Cancer-Related Fatigue Among Cancer Survivors: Systematic Review and Meta-Analysis.Integrative cancer therapiesPooled it
- Bayesian adaptive randomized trial of blended cognitive behavioral therapy for severe fatigue in stable diffuse glioma.Neuro-oncology · 2026Trial
- Effects of cognitive behavioral therapy for insomnia and armodafinil on quality of life in cancer survivors: a randomized placebo-controlled trial.Journal of cancer survivorship : research and practice · 2017Trial
- A randomized, placebo-controlled pilot trial of armodafinil for fatigue in patients with gliomas undergoing radiotherapy.Neuro-oncology · 2016Trial
- Cognitive behavioral therapy for insomnia, but not armodafinil, improves fatigue in cancer survivors with insomnia: a randomized placebo-controlled trial.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2016Trial
- Effects of armodafinil and cognitive behavior therapy for insomnia on sleep continuity and daytime sleepiness in cancer survivors.Sleep medicine · 2016Trial
- Phase II double-blind placebo-controlled randomized study of armodafinil for brain radiation-induced fatigue.Neuro-oncology · 2015Trial
- A phase 3 trial of armodafinil for the treatment of cancer-related fatigue for patients with multiple myeloma.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2015Trial
- Methodology of analysis of cognitive impairment in longitudinal randomized clinical trials in oncology: a scoping review.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026Article
- Glioblastoma in adults: A Society for Neuro-Oncology (SNO) and European Society of Neuro-Oncology (EANO) consensus review on current management and future directions.Neuro-oncology · 2025Review
- Cyclodextrin-Based Formulations as a Promising Strategy to Overcome the Blood-Brain Barrier: Historical Overview and Prospects in Glioblastoma Treatment.Pharmaceuticals (Basel, Switzerland) · 2025Review
- Approaches to Reduce Toxicity in Pediatric Brain Tumors.Current oncology (Toronto, Ont.) · 2025Review
6 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundFatigue, cognitive deficits, and depression are frequently reported but often undertreated symptoms that can profoundly affect daily life in patients with primary brain tumors (PBTs). To evaluate the effects of the psychostimulant modafinil on fatigue, depression, health-related quality of life (HRQOL), and cognitive functioning in PBT patients, we performed a multicenter, double-blind placebo-controlled crossover trial.
methodsPatients randomly received either 6 weeks of treatment with modafinil (up to 400 mg/day) or 6 weeks with placebo. After a 1-week washout period, the opposite treatment was provided. Assessments took place at baseline and immediately after the first and second condition. Patients completed self-report questionnaires on fatigue (Checklist Individual Strength [CIS]), depression (Center for Epidemiologic Studies Depression Scale [CES-D]), HRQOL (Short-Form Health Survey [SF-36]), and self-perceived cognitive functioning (Medical Outcomes Study [MOS]). They also underwent comprehensive neurocognitive testing.
resultsIn total, 37 patients participated. Relative to baseline, patients reported lower fatigue severity (CIS) and better motivation (CIS) in both the modafinil (P = .010 and P = .021, respectively) and the placebo condition (P < .001 and P = .027, respectively). The same held for physical health (SF-36 Physical Component Summary score; P = .001 and P = .008, respectively), working memory (P = .040 and P = .043), and information processing capacity (P = .036 and P = .040). No improvement in depressive symptoms was found in either condition.
conclusionsModafinil did not exceed the effects of placebo with respect to symptom management. Patient accrual was slow, and relatively many patients dropped out during the trial, due mostly to side effects. Other, preferably nonpharmacologic intervention studies should be considered to improve symptom management of PBT patients.
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