Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2013 Oct;15(10):1420-8.
doi: 10.1093/neuonc/not102. Epub 2013 Aug 7.

The effect of modafinil on fatigue, cognitive functioning, and mood in primary brain tumor patients: a multicenter randomized controlled trial

Florien W Boele  1 , Linda Douw, Marjolein de Groot, Hinke F van Thuijl, Wilmy Cleijne, Jan J Heimans, Martin J B Taphoorn, Jaap C Reijneveld, Martin Klein
Affiliations
Randomized Controlled Trial

The effect of modafinil on fatigue, cognitive functioning, and mood in primary brain tumor patients: a multicenter randomized controlled trial

Florien W Boele et al. Neuro Oncol. 2013 Oct.

Abstract

Background: Fatigue, 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.

Methods: Patients 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.

Results: In 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.

Conclusions: Modafinil 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.

Keywords: HRQOL; brain tumor; cognitive functioning; fatigue; modafinil; mood.

PubMed Disclaimer

Figures

Fig. 1.
Fig. 1.
Participant flow.
See this image and copyright information in PMC

References

    1. Taphoorn MJB, Klein M. Cognitive deficits in adult patients with brain tumours. Lancet Neurol. 2004;3:159–168. - PubMed
    1. Weitzner MA. Psychosocial and neuropsychiatric aspects of patients with primary brain tumors. Cancer Invest. 1999;17:285–291. - PubMed
    1. Powell C, Guerrero D, Sardell S, et al. Somnolence syndrome in patients receiving radical radiotherapy for primary brain tumours: a prospective study. Radiother Oncol. 2011;100:131–136. - PubMed
    1. Faithful S, Brada M. Somnolence syndrome in adults following cranial irradiation for primary brain tumours. Clinical Oncol. 1998;10:250–254. - PubMed
    1. Struik K, Klein M, Heimans JJ, et al. Fatigue in low-grade glioma. J Neurooncol. 2008;92:73–78. - PubMed

Publication types

MeSH terms