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

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.

• Authors: Brandi R 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
• Journal: Neuro-oncology (Neuro Oncol) Vol. 17 Issue 10 Pg. 1393-401 (Oct 2015) ISSN: 1523-5866 [Electronic] England
• PMID: 25972454 (Publication Type: Clinical Trial, Phase II, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © The Author(s) 2015. Published by Oxford University Press on behalf of the Society for Neuro-Oncology. All rights reserved. For permissions, please e-mail: [email protected].

Chemical References

• Benzhydryl Compounds
• Wakefulness-Promoting Agents
• Modafinil

Topics

• Adult
• Aged
• Benzhydryl Compounds (administration & dosage, adverse effects, therapeutic use)
• Brain Neoplasms (radiotherapy)
• Double-Blind Method
• Fatigue (etiology, prevention & control)
• Female
• Glioblastoma (complications, radiotherapy)
• Humans
• Male
• Meningioma (complications, radiotherapy)
• Middle Aged
• Modafinil
• Quality of Life
• Radiotherapy (adverse effects)
• Treatment Outcome
• Wakefulness-Promoting Agents (therapeutic use)