Malignant Glioma Clinical Trial
Official title:
A Randomized Placebo-Controlled Trial of Armodafinil (Nuvigil) for Fatigue in Patients With Malignant Gliomas Undergoing Radiotherapy With or Without Standard Chemotherapy Treatment
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.
- Since no one knows for certain if armodafinil improves fatigue in brain tumor patients
undergoing radiation therapy, participants will be randomized into one of two study
groups. Half of the participants will receive armodafinil and the other half will
receive pills with no medicine (placebo). Neither the participant or the study doctor
will know what group they are in.
- Participants will be given a study medication-dosing calendar and will take either the
study drug or placebo orally once a day for 8 weeks. The dose will be adjusted on days
8,22 or 43, depending upon the level of fatigue. Treatment will begin within 10 days
from the radiation start date.
- Participants will be evaluated via documented clinician telephone call and
self-administered questionnaires on days 1, 8, 22, 43 and 57.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
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