A Randomized Placebo-Controlled Trial of Armodafinil (Nuvigil) for Fatigue in Patients With Malignant Gliomas Undergoing Radiotherapy With or Without Standard Chemotherapy Treatment
- 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
To estimate the difference between the two groups in treatment of fatigue in patients with malignant gliomas undergoing radiotherapy.
Eudocia Lee, MD
Dana-Farber Cancer Institute
United States: Institutional Review Board
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Dartmouth-Hitchcock Medical Center||Lebanon, New Hampshire 03756|
|UCSD San Diego||La Jolla, California|