A Randomized Placebo-Controlled Trial of Armodafinil (Nuvigil) for Fatigue in Patients With Malignant Gliomas

Eudocia Quant Lee, MD

Status and phase

Completed

Phase 2

Conditions

Malignant Glioma

Treatments

Other: Placebo

Drug: Armodafinil

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00766467

07-341

Details and patient eligibility

About

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.

Full description

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.

Enrollment

81 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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