A Phase III Study of Armodafinil versus Placebo to Reduce Cancer-Related Fatigue in Patients with High-Grade Glioma

Full Title

A Phase III Randomized, Double-Blind Placebo Controlled Study of Armodafinil (Nuvigil®) To Reduce Cancer-Related Fatigue in Patients with High Grade Glioma (A221101) Back to top

Purpose

Armodafinil (Nuvigil) is a drug that activates parts of the brain which maintain a state of wakefulness and alertness. It is used to treat people with sleep disorders as well as people who have fatigue as a result of neurologic problems.

In this study, researchers want to know if armodafinil is useful for treating cancer-related fatigue in patients with a type of brain tumor called high-grade glioma. Examples of high-grade gliomas include glioblastoma, anaplastic astrocytoma, and anaplastic oligodendroglioma. Patients will be randomly assigned to receive 150 mg of armodafinil per day, 250 mg of armodafinil per day, or a placebo (sugar pill) for eight weeks. Armodafinil is taken orally (by mouth).

Patients will complete questionnaires about their cancer-related fatigue and also take memory and concentration skills tests.

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Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have high-grade glioma (glioblastoma, anaplastic astrocytoma, or anaplastic oligodendroglioma) and be experiencing cancer-related fatigue.
  • Patients must have had surgery for their glioma and must have completed radiation therapy at least 4 weeks but no more than 2 years before entering the study.
  • This study is for patients age 18 and older.

For more information about this study, please contact Dr. Eli Diamond at 212-639-7576.

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Protocol

14-040

Phase

III

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator

Co-Investigators