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

Neuro-oncology
Eudocia Q LeePatrick Y Wen

Abstract

Fatigue is common among glioma patients undergoing radiotherapy (RT) and impacts quality of life (QOL). We evaluated whether armodafinil, a wakefulness-promoting medication, improves fatigue in glioma patients undergoing RT. Eligibility criteria included age ≥18 years, Karnofsky performance status ≥60, and grade 2-4 glioma undergoing RT to a total dose of 50-60 Gy. Patients were randomized 1:1 to armodafinil or placebo for 8 weeks beginning within 10 days of starting RT. Fatigue and QOL were assessed at baseline, day 22, day 43, and day 56 with the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F), the Functional Assessment of Cancer Therapy - General (FACT-G), the Brief Fatigue Inventory (BFI), and the Cancer Fatigue Scale (CFS). The primary aim was to detect a difference in the 42-day change in FACIT-F fatigue subscale between the 2 groups using a 2-sample Wilcoxon statistic. We enrolled 81 patients total (42 armodafinil and 39 placebo). Armodafinil did not significantly improve fatigue or QOL based on the 42-day change in FACIT-F fatigue subscale, FACT-G, CFS, or BFI. Further analysis suggests no difference between the arms even after accounting for the potential bias of missing data. Treatment was well to...Continue Reading

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Citations

May 26, 2017·Journal of Neuro-oncology·Ellen M P van Coevorden-van LoonMartin J van den Bent
Jan 25, 2020·Journal of Neuro-oncology·Stine ScheiLisa Millgård Sagberg
Jan 21, 2017·Journal of Cancer Survivorship : Research and Practice·Anita R PeoplesJoseph A Roscoe
Jan 1, 2016·Expert Review of Quality of Life in Cancer Care·Chao-Pin HsiaoLeorey N Saligan
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Jul 1, 2020·Current Neurology and Neuroscience Reports·David Schiff, Mossaed Alyahya
Jul 1, 2020·Current Neurology and Neuroscience Reports·Rifaquat RahmanPatrick Y Wen
Mar 17, 2020·Annals of Oncology : Official Journal of the European Society for Medical Oncology·A FabiUNKNOWN ESMO Guidelines Committee. Electronic address: clinicalguidelines@esmo.org
Dec 5, 2020·Continuum : Lifelong Learning in Neurology·Deborah A Forst
Mar 4, 2021·Cancers·Caritha KlassonLinda Björkhem-Bergman
Mar 2, 2021·British Journal of Nursing : BJN·Mohammed Al Maqbali
Jun 4, 2021·Irish Journal of Medical Science·Qingbei LianDidong Xie
Jul 19, 2021·Cancer radiothérapie : journal de la Société française de radiothérapie oncologique·M Le Guyader, D Antoni

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