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Armodafinil in Reducing Cancer-Related Fatigue in Patients With High Grade Glioma
||A221101: A Phase III Randomized, Double-Blind Placebo Controlled Study of Armodafinil (Nuvigil®) To Reduce Cancer-Related Fatigue in Patients with High Grade Glioma
Brain Cancer, Brain Tumors
||Suriya Jeyapalan, MD
This randomized phase III trial studies armodafinil to see how well it works in reducing cancer-related fatigue in patients with high grade glioma. Armodafinil may help relieve fatigue in patients with high grade glioma.
- Subjects must have glioblastoma, anaplastic astrocytoma, anaplastic oligodendroglioma, or anaplastic oligoastrocytoma
- Undergone surgery (gross total or subtotal resection) or biopsy and will have been treated with concurrent radiation therapy and chemotherapy
- Ability to complete questionnaire(s) by themselves or with assistance
- Pregnant and/or nursing women. Men or women of childbearing potential who are unwilling to employ adequate contraception
- History of hypersensitivity to other psycho-stimulants
- History of steroid psychosis
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.