Clinical Trials

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1. Armodafinil in Reducing Cancer-Related Fatigue in Patients With Glioblastoma Multiforme Scottsdale and Phoenix, AZ Rochester, MN View Summary
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   Armodafinil in Reducing Cancer-Related Fatigue in Patients With Glioblastoma Multiforme

   Location:

   Scottsdale and Phoenix, AZ Rochester, MN

   Trial status:

   Open for Enrollment

   Why is this study being done?

   PRIMARY OBJECTIVES: I. To determine preliminary efficacy measured by patient reported fatigue (Brief Fatigue Inventory [BFI]) at 8 weeks of two doses (150mg and 250mg) of armodafinil in treating moderate fatigue compared to placebo in patients with glioblastoma. SECONDARY OBJECTIVES: I. To evaluate the tolerability at 8 weeks of 150mg and 250mg armodafinil in this patient population. II. To assess the effect of armodafinil at 8 weeks on cognitive function in patients with glioblastoma. III. To assess the impact of armodafinil on global quality of life and other fatigue endpoints (i.e. usual fatigue, activity interference) in this patient population with glioblastoma. IV. Explore the correlation between the BFI, Patient-Reported Outcomes Measurement Information System (PROMIS), and Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) measures, as well as the relationship of fatigue and cognitive difficulties. OUTLINE: Patients are randomized to 1 of 3 treatment arms. ARM I: Patients receive lower-dose armodafinil orally (PO) once daily (QD) on days 1-28. ARM II: Patients receive placebo PO QD on days 1-28. ARM III: Patients receive higher-dose armodafinil PO QD on days 1-28. In all arms, treatment repeats every 28 days for 2 courses.

   NCT ID:

   NCT01781468

   IRB Number:

   12-008547

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