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

Boele, Florien; Douw, Linda; Groot, M. de; Thuijl, Hinke F. van; Cleijne, Wilmy; Heimans, Jan J.; Taphoorn, Martin J.B.; Reijneveld, Jaap C.; Klein, Martin

doi:10.1093/neuonc/not102

Cited by 111 publications

(92 citation statements)

References 51 publications

(38 reference statements)

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“…This is consistent with other trials that have not demonstrated an effect of armodafinil or modafinil on fatigue in cancer patients [24-26]. Trials in populations other than cancer have reported a significant improvement in daytime fatigue with the use of armodafinil [40-42].…”

Section: Discussionsupporting

confidence: 89%

“…In one study, modafinil was shown to elicit modest improvement in chemotherapy-related fatigue in patients with metastatic breast or prostate cancer [24]. By contrast, other studies have shown that modafinil was not significantly different from placebo for reducing fatigue in patients with lung cancer [25] or primary brain tumor [26]. Similarly, armodafinil (the R enantiomer of modafinil) was not significantly different than placebo in reducing fatigue in patients with multiple myeloma [27].…”

Section: Introductionmentioning

confidence: 99%

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Cognitive behavioral therapy for insomnia, but not armodafinil, improves fatigue in cancer survivors with insomnia: a randomized placebo-controlled trial

Heckler

Garland

Peoples

et al. 2015

Support Care Cancer

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Purpose Fatigue is a prevalent, distressing side effect of cancer and cancer treatment which commonly co-exists with insomnia. Cognitive behavioral therapy for insomnia (CBT-I) has been shown to improve insomnia in cancer patients, but less is known about its ability to impact fatigue. This work is the analysis for a secondary aim of a 4-arm RCT study assessing the combined and comparative effect of CBT-I and a wakefulness-promoting agent, armodafinil (A), to improve sleep and daytime functioning in cancer survivors. Herein, we examine the effect of CBT-I, with and without A, on fatigue in cancer survivors. Patients and Methods This study was a four arm factorial study with CBTI-I (Yes/No) versus A (Yes/No). It consisted of 96 cancer survivors (Average age 56 years; 88% female; 68% breast cancer). Fatigue was assessed by the Brief Fatigue Inventory (BFI) and the FACIT-Fatigue scale. The analysis assessed the additive effects of CBT-I and A, and possible non-additive effects where the effect of CBT-I changes depending on the presence or absence of A. Results Analyses adjusting for baseline differences showed that CBT-I improved fatigue as measured by two separate scales (BFI: P=0.002, Std. Error=0.32, effect size (ES)=0.46; FACIT-Fatigue: P<0.001, Std. Error=1.74, ES=0.64). Armodafinil alone did not show a statistically significant effect on fatigue levels (all Ps>0.40), nor did the drug influence the efficacy of CBT-I. Structural equation analysis revealed that reductions in insomnia severity were directly responsible for improving cancer-related fatigue. Conclusions CBT-I with and without armodafinil resulted in a clinically and statistically significant reduction of subjective daytime fatigue in cancer survivors with chronic insomnia. Armodafinil did not improve CRF and did not change the efficacy of CBT-I. Patients reporting CRF should be screened and, if indicated, treated for insomnia as part of a comprehensive fatigue management program.

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Section: Discussionsupporting

confidence: 89%

Section: Introductionmentioning

confidence: 99%

Cognitive behavioral therapy for insomnia, but not armodafinil, improves fatigue in cancer survivors with insomnia: a randomized placebo-controlled trial

Heckler

Garland

Peoples

et al. 2015

Support Care Cancer

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“…34 Other studies report no evidence of benefit on depressive symptoms. 22,23,[35][36][37] These negative results are difficult to interpret because these studies were neither focused on, nor powered to exclude an effect on depression.…”

Section: Mood and Behavioural Disordersmentioning

confidence: 97%

“…21 A 6-week crossover study of modafinil versus placebo in stable brain tumour patients with moderate fatigue showed reduction in fatigue severity in both arms, but no significant benefit from modafinil over placebo. 22 Several RCTs examined the effect of methylphenidate or armodafinil on fatigue in patients undergoing radiotherapy for brain metastases. 23,24 These studies failed to find a significant reduction in fatigue, although post-hoc analyses noted improvement at 4-week follow-up in those with high baseline fatigue and a trend towards improvement at 6-week follow-up using armodafanil.…”

Section: Venous Thromboembolismmentioning

confidence: 99%

“…25 Modafinil, in a more recent double-blind placebo-controlled crossover trial in 37 primary brain tumour patients, did not exceed the (positive) effects of placebo in terms of cognitive functioning. 22 In three randomized studies the effect of cognitive rehabilitation to improve cognitive functioning was examined. [47][48][49] In one of these studies, virtual reality training was added to standard computer-based cognitive rehabilitation in 19 of 38 brain tumour patients and significantly improved several cognitive outcomes.…”

Section: Cognitionmentioning

confidence: 99%

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European Association for Neuro-Oncology (EANO) guidelines for palliative care in adults with glioma

Pace¹,

Dirven

Koekkoek

et al. 2017

The Lancet Oncology

222

184

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Patients with glioma present with complex palliative care needs throughout their disease trajectory. The life-limiting nature of gliomas and the presence of specific symptoms related to neurological deterioration necessitate an appropriate and early palliative care approach. The multidisciplinary palliative care task force of the European Association of Neuro-Oncology did a systematic review of the available scientific literature to formulate the best possible evidence-based recommendations for the palliative care of adult patients with glioma, with the aim to reduce symptom burden and improve the quality of life of patients and their caregivers, particularly in the end-of-life phase. When recommendations could not be made because of the scarcity of evidence, the task force either used evidence from studies of patients with systemic cancer or formulated expert opinion. Areas of palliative care that currently lack evidence and thus deserve attention for further research are fatigue, disorders of behaviour and mood, interventions for the needs of caregivers, and timing of advance care planning.

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Pharmacological treatment of depression in people with a primary brain tumour

Beevers

Hussain

Boele

et al. 2020

Cochrane Database of Systematic Reviews

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

Cited by 111 publications

References 51 publications

Cognitive behavioral therapy for insomnia, but not armodafinil, improves fatigue in cancer survivors with insomnia: a randomized placebo-controlled trial

Cognitive behavioral therapy for insomnia, but not armodafinil, improves fatigue in cancer survivors with insomnia: a randomized placebo-controlled trial

European Association for Neuro-Oncology (EANO) guidelines for palliative care in adults with glioma

Pharmacological treatment of depression in people with a primary brain tumour

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