A Randomized Placebo-Controlled Trial of Armodafinil (Nuvigil) for Fatigue in Patients With Malignant Gliomas
Condition: Malignant Glioma
MeSH terms: Glioma; Fatigue
Intervention: Armodafinil; Placebo
Intervention description: Taken orally once a day in the morning. Dose will change depending upon level of fatigue; Placebo taken once a day in the morning
Intervention MeSH terms: Modafinil
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 81.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: armodafinil; Nuvigil; fatigue

Summary:

      The purpose of this research study is to determine if armodafinil is safe and effective in
      treating fatigue in patients with malignant gliomas undergoing treatment with radiotherapy
      plus temodar. Armodafinil is a wakefulness-promoting agent that has been FDA approved for the
      treatment of excessive daytime sleepiness for a variety of disorders. Armodafinil may also
      help to reduce radiation-induced fatigue in brain tumor patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years of age or older

          -  Histologically confirmed malignant glioma including anaplastic astrocytoma, anaplastic
             oligodendroglioma, anaplastic oligoastrocytoma (WHO grade III/IV), glioblastoma
             multiforme (WHO grade IV) or gliosarcoma. Patients with a grade II astrocytoma, mixed
             oligo-astrocytoma or oligodendroglioma who are being treated with irradiation are also
             eligible

          -  Scheduled to receive irradiation to a total dose of 50-60 Gy. Patients receiving
             hyperfractionated radiotherapy are also eligible

          -  KPS of 70% or greater

          -  Electrolytes within normal institutional limits: BUN and Creatinine < 2.5 x ULN: AST,
             ALT, Bilirubin < 2.5 x ULN

          -  Able to swallow medication

        Exclusion Criteria:

          -  History of recent cardiac arrhythmia or unstable angina

          -  Has taken a psychostimulant or a monoamine oxidase inhibitor on a regular basis within
             the past 30 days

          -  Clinically significant untreated sleep apnea

          -  A history of clinically significant cardiac disease, including a history of recent
             myocardial infarction, history of unstable angina, history of left ventricular
             hypertrophy, or a history of ischemic ECG changes, chest pain, arrhythmia, or other
             clinically significant manifestations of mitral valve prolapse in association with use
             of CNS stimulants (e.g. caffeine, amphetamines, methylphenidate)

          -  Uncontrolled hypertension, alcohol or drug abuse, severe headaches, glaucoma,
             narcolepsy, clinically significant untreated sleep apnea, psychotic disorder or
             Tourette's syndrome

          -  Patients taking warfarin for anticoagulation are eligible, but monitoring of
             prothrombin times is suggested as a precaution

          -  Hemoglobin level of less then 11 g/dl

          -  Laboratory evidence of hypothyroidism with an elevated TSH concentration in the blood
             greater than 5.0 mlU/L

          -  Current treatment or history of psychotic disorder, bipolar disorder, or anxiety
             disorder

          -  Patients with a score of > 28 on the Beck depression inventory consistent with severe
             depression

          -  Known hypersensitivity to armodafinil or related compounds

          -  Patients who have been receiving MAO inhibitors during the past 14 days