Phase II double-blind placebo-controlled randomized study of armodafinil for brain radiation-induced fatigue

Brandi Page, Edward G. Shaw, Lingyi Lu, David Bryant, David Grisell, Glenn J. Lesser, Drew C. Monitto, Michelle J. Naughton, Stephen R. Rapp, Steven R. Savona, Sunjay Shah, Doug Case, Michael D. Chan

Research output: Contribution to journalArticle

Abstract

Background Common acute-term side effects of brain radiotherapy (RT) include fatigue, drowsiness, decreased physical functioning, and decreased quality of life (QOL). We hypothesized that armodafinil (a wakefulness-promoting drug known to reduce fatigue and increase cognitive function in breast cancer patients receiving chemotherapy) would result in reduced fatigue and sleepiness for patients receiving brain RT. Methods A phase II, multi-institutional, placebo-controlled randomized trial assessed feasibility of armodafinil 150 mg/day in participants receiving brain RT, from whom we obtained estimates of variability for fatigue, sleepiness, QOL, cognitive function, and treatment effect. Results From September 20, 2010, to October 20, 2012, 54 participants enrolled with 80% retention and 94% self-reported compliance. There were no grade 4-5 toxicities, and the incidence of grade 2-3 toxicities was similar between treatment arms, the most common of which were anxiety and nausea (15%), headaches (19%), and insomnia (20%). There were no statistically significant differences in end-RT or 4 week post-RT outcomes between armodafinil and placebo in any outcomes (Functional Assessment of Chronic Illness Therapy [FACIT]-Fatigue, Brief Fatigue Inventory, Epworth Sleepiness Scale, FACT-Brain, and FACIT-cognitive function). However, in participants with more baseline fatigue, those treated with armodafinil did better than those who received the placebo on the end-RT assessments for several outcomes. Conclusion Armodafinil 150 mg/day was well tolerated in primary brain tumor patients undergoing RT with good compliance. While there was no overall significant effect on fatigue, those with greater baseline fatigue experienced improved QOL and reduced fatigue when using armodafinil. These data suggest that a prospective, phase III randomized trial is warranted for patients with greater baseline fatigue.

Original languageEnglish (US)
Pages (from-to)1393-1401
Number of pages9
JournalNeuro-Oncology
Volume17
Issue number10
DOIs
StatePublished - Oct 1 2015
Externally publishedYes

Fingerprint

Fatigue
Placebos
Radiation
Brain
Radiotherapy
Cognition
Quality of Life
armodafinil
Chronic Disease
Outcome Assessment (Health Care)
Wakefulness
Sleep Stages
Sleep Initiation and Maintenance Disorders
Therapeutics
Brain Neoplasms
Nausea
Compliance
Headache
Anxiety
Randomized Controlled Trials

Keywords

  • armodafinil
  • cognitive function
  • fatigue
  • primary brain tumors
  • radiotherapy

ASJC Scopus subject areas

  • Cancer Research
  • Oncology
  • Clinical Neurology

Cite this

Phase II double-blind placebo-controlled randomized study of armodafinil for brain radiation-induced fatigue. / Page, Brandi; Shaw, Edward G.; Lu, Lingyi; Bryant, David; Grisell, David; Lesser, Glenn J.; Monitto, Drew C.; Naughton, Michelle J.; Rapp, Stephen R.; Savona, Steven R.; Shah, Sunjay; Case, Doug; Chan, Michael D.

In: Neuro-Oncology, Vol. 17, No. 10, 01.10.2015, p. 1393-1401.

Research output: Contribution to journalArticle

Page, B, Shaw, EG, Lu, L, Bryant, D, Grisell, D, Lesser, GJ, Monitto, DC, Naughton, MJ, Rapp, SR, Savona, SR, Shah, S, Case, D & Chan, MD 2015, 'Phase II double-blind placebo-controlled randomized study of armodafinil for brain radiation-induced fatigue', Neuro-Oncology, vol. 17, no. 10, pp. 1393-1401. https://doi.org/10.1093/neuonc/nov084
Page, Brandi ; Shaw, Edward G. ; Lu, Lingyi ; Bryant, David ; Grisell, David ; Lesser, Glenn J. ; Monitto, Drew C. ; Naughton, Michelle J. ; Rapp, Stephen R. ; Savona, Steven R. ; Shah, Sunjay ; Case, Doug ; Chan, Michael D. / Phase II double-blind placebo-controlled randomized study of armodafinil for brain radiation-induced fatigue. In: Neuro-Oncology. 2015 ; Vol. 17, No. 10. pp. 1393-1401.
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abstract = "Background Common acute-term side effects of brain radiotherapy (RT) include fatigue, drowsiness, decreased physical functioning, and decreased quality of life (QOL). We hypothesized that armodafinil (a wakefulness-promoting drug known to reduce fatigue and increase cognitive function in breast cancer patients receiving chemotherapy) would result in reduced fatigue and sleepiness for patients receiving brain RT. Methods A phase II, multi-institutional, placebo-controlled randomized trial assessed feasibility of armodafinil 150 mg/day in participants receiving brain RT, from whom we obtained estimates of variability for fatigue, sleepiness, QOL, cognitive function, and treatment effect. Results From September 20, 2010, to October 20, 2012, 54 participants enrolled with 80{\%} retention and 94{\%} self-reported compliance. There were no grade 4-5 toxicities, and the incidence of grade 2-3 toxicities was similar between treatment arms, the most common of which were anxiety and nausea (15{\%}), headaches (19{\%}), and insomnia (20{\%}). There were no statistically significant differences in end-RT or 4 week post-RT outcomes between armodafinil and placebo in any outcomes (Functional Assessment of Chronic Illness Therapy [FACIT]-Fatigue, Brief Fatigue Inventory, Epworth Sleepiness Scale, FACT-Brain, and FACIT-cognitive function). However, in participants with more baseline fatigue, those treated with armodafinil did better than those who received the placebo on the end-RT assessments for several outcomes. Conclusion Armodafinil 150 mg/day was well tolerated in primary brain tumor patients undergoing RT with good compliance. While there was no overall significant effect on fatigue, those with greater baseline fatigue experienced improved QOL and reduced fatigue when using armodafinil. These data suggest that a prospective, phase III randomized trial is warranted for patients with greater baseline fatigue.",
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AU - Shaw, Edward G.

AU - Lu, Lingyi

AU - Bryant, David

AU - Grisell, David

AU - Lesser, Glenn J.

AU - Monitto, Drew C.

AU - Naughton, Michelle J.

AU - Rapp, Stephen R.

AU - Savona, Steven R.

AU - Shah, Sunjay

AU - Case, Doug

AU - Chan, Michael D.

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