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Armodafinil in Reducing Cancer-Related Fatigue in Patients With High Grade Glioma


Title A221101: A Phase III Randomized, Double-Blind Placebo Controlled Study of Armodafinil (Nuvigil®) To Reduce Cancer-Related Fatigue in Patients with High Grade Glioma
Therapeutic Area Glioma (adult), Brain Tumors
Principal Investigator Suriya Jeyapalan, MD
Min Age 18 Years
Gender Both
Contact Amy Quinkert
617-636-8589
More Information https://clinicaltrials.gov/ct2/show/NCT01781468

Overview

The purpose of this study is to:  1) see if taking the study agent, armodafinil, at a dose of 150mg or 250mg, will improve problems with fatigue in subjects who have been diagnosed with cancer and are experiencing fatigue; and 2) see the effects (good and bad) of taking Armodafinil compared to placebo (an inactive agent) on cancer related fatigue. In this study, subjects will take either the study agent, armodafinil, or the placebo (inactive agent).  Subjects will not take both. Armodafinil (Nuvigil®) is a medicine that is currently FDA approved to promote wakefulness in people who have sleep disorders.   However, it is not been studied in people with cancer related fatigue.

Study Details

Inclusion Criteria

  • Subjects must have glioblastoma, anaplastic astrocytoma, anaplastic oligodendroglioma, or anaplastic oligoastrocytoma.
  • Subjects must be able to complete questionnaires by themselves or with assistance.

Exclusion Criteria

  • No pregnant or nursing women.
  • Subjects must not be on psychostimulants or be taking other treatments for fatigue.
  • No other complicating malignancies such as intractable epilepsy or uncontrolled seizure disorder.

Study Requirements

Subjects will be randomized to take the study drug, armodafinil at 150mg, armodafinil at 250mg, or placebo. Subjects will take the study drugs every day for 8 weeks. Subjects will be asked to fill out questionnaires and undergo neurocognitive tests at baseline, after 4 weeks taking the study drug, and after 8 weeks taking the study drug.