A randomized, placebo-controlled pilot trial of armodafinil for fatigue in patients with gliomas undergoing radiotherapy

Lee, Eudocia Q.; Muzikansky, Alona; Drappatz, Jan; Kesari, Santosh; Wong, Eric T.; Fadul, Camilo E.; Reardon, David A.; Norden, Andrew D.; Nayak, Lakshmi; Rinne, Mikael L.; Alexander, Brian M.; Arvold, Nils D.; Doherty, Lisa; Stefanik, Jennifer; LaFrankie, Debra C.; Ruland, Sandra; Pulverenti, Julee; Smith, Katrina H.; Gaffey, Sarah; Hammond, Samantha N.; Wen, Patrick Y.

doi:10.1093/neuonc/now007

Cited by 51 publications

(43 citation statements)

References 16 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…In our published manuscript on the primary study aim for insomnia [30], we also saw no effect of armodafinil on insomnia or sleep quality. This lack of significant effect is consistent with previous trials that have also demonstrated no effect of armodafinil on QOL in patients with cancer, even for doses as high as 400 mg/day [40–43]. This might be due to the fact that it may be difficult to improve insomnia beyond the effects produced by CBT-I, as several well-conducted RCTs have indicated that CBT-I produces robust clinical improvements in cancer-related sleep problems [18].…”

Section: Discussionsupporting

confidence: 91%

Effects of cognitive behavioral therapy for insomnia and armodafinil on quality of life in cancer survivors: a randomized placebo-controlled trial

et al. 2017

View full text Add to dashboard Cite

Purpose Cancer-related insomnia is associated with diminished quality of life (QOL), suggesting that improvement in insomnia may improve QOL in cancer survivors. Cognitive behavioral therapy for insomnia (CBT-I) has been shown to improve insomnia, but less is known regarding its effect on QOL and whether improvement in insomnia corresponds to improved QOL. The present analysis examines the effects of CBT-I, with and without armodafinil, on QOL both directly and indirectly through improvements of insomnia. Methods This is an analysis of 95 cancer survivors for a specified secondary aim of a 4-arm randomized controlled trial assessing the combined and individual effects of CBT-I and armodafinil to improve insomnia. QOL and insomnia severity were assessed before, during the intervention, at post-intervention, and three months later by Functional Assessment of Cancer Therapy-General and Insomnia Severity Index, respectively. Results Mean change in QOL from pre- to post-intervention for CBT-I+placebo, CBT-I+armodafinil, armodafinil, and placebo was: 9.6 (SE=1.8; p<0.0001), 11.6 (SE=1.8; p<0.0001), −0.2 (SE=3.2; p=0.964), and 3.3 (SE=2.0; p=0.124), respectively. ANCOVA controlling for pre-intervention scores showed that participants receiving CBT-I had significantly improved QOL at post-intervention compared to those not receiving CBT-I (p<0.0001, effect size=0.57), with benefits being maintained at the three-month follow-up. Path analysis revealed that this improvement in QOL was due to improvement in insomnia severity (p=0.002), and Pearson correlations showed that changes in QOL from pre- to post-intervention were significantly associated with concurrent changes in insomnia severity (r=−0.56; p<0.0001). Armodafinil had no effect on QOL for those who did or did not receive it (p=0.976; effect size=−0.004). Conclusion In cancer survivors with insomnia, CBT-I resulted in clinically significant improvement in QOL via improvement in insomnia. This improvement in QOL remained stable even three months after completing CBT-I. Implications for Cancer Survivors Considering the high prevalence of insomnia and its detrimental impact on QOL in cancer survivors and the effectiveness of CBT-I in alleviating insomnia, it is important that evidence-based non-pharmacological sleep interventions such as CBT-I be provided as an integral part of cancer care.

show abstract

Section: Discussionsupporting

confidence: 91%

Effects of cognitive behavioral therapy for insomnia and armodafinil on quality of life in cancer survivors: a randomized placebo-controlled trial

et al. 2017

View full text Add to dashboard Cite

show abstract

“…Two studies used two or more instruments [18, 19]. Table 3 shows a short description and the internal consistency of the measurement instruments.…”

Section: Resultsmentioning

confidence: 99%

Fatigue in patients with low grade glioma: systematic evaluation of assessment and prevalence

et al. 2017

View full text Add to dashboard Cite

Fatigue is the most prevalent and disabling symptom in cancer patients. Yet, scientific literature on this topic is scarce and reports disparate results. This study systematically reviews how fatigue is assessed in patients with low-grade glioma and evaluates its prevalence in LGG patients. A systematic literature search was performed in PubMed, Embase and PsychINFO for articles reporting on fatigue in patients with LGG. Two reviewers independently extracted data from selected articles. Inclusion criteria were: (1) patients with suspected or confirmed LGG; (2) fatigue was assessed as primary or secondary outcome measure; (3) age≥ 18 years; (4) full-length article written in English or Dutch. In total, 19 articles were selected, including 971 patients. Seven self-assessment instruments were identified. Prevalence rates ranged from 39 to 77%. Fatigue was found to be a common side effect of treatment. The prevalence rates ranged from 20 to 76% when fatigue was reported as a mild or moderate side effect and fatigue was prevalent in 4% when reported as a severe side effect. Fatigue is a common problem in LGG patients that warrants more therapeutic and scientific attention. Gaining deeper insight in the underlying mechanisms of fatigue is essential in targeting therapy to individual patients.

show abstract

“…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: 96%

“…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. 23 Thus, there is no evidence suggesting a significant benefit from modafinil, armodafinil, methylphenidate or donepezil for the treatment of fatigue in stable brain tumour patients after treatment.…”

Section: Venous Thromboembolismmentioning

confidence: 99%

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

Pace¹,

Dirven

Koekkoek

et al. 2017

The Lancet Oncology

231

184

View full text Add to dashboard Cite

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.

show abstract

A randomized, placebo-controlled pilot trial of armodafinil for fatigue in patients with gliomas undergoing radiotherapy

Abstract: While treatment was well-tolerated, an 8-week course of armodafinil did not improve fatigue or QOL in glioma patients undergoing RT in this pilot study. Further studies are needed to determine whether pharmacologic treatment improves fatigue in glioma patients undergoing RT.

Cited by 51 publications

References 16 publications

Effects of cognitive behavioral therapy for insomnia and armodafinil on quality of life in cancer survivors: a randomized placebo-controlled trial

Effects of cognitive behavioral therapy for insomnia and armodafinil on quality of life in cancer survivors: a randomized placebo-controlled trial

Fatigue in patients with low grade glioma: systematic evaluation of assessment and prevalence

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

Contact Info

Product

Resources

About