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A Randomized Placebo-Controlled Trial of Armodafinil (Nuvigil) for Fatigue in Patients With Malignant Gliomas Undergoing Radiotherapy With or Without Standard Chemotherapy Treatment

Phase 2
18 Years
Open (Enrolling)
Malignant Glioma

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Trial Information

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.

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

- Life expectancy of six months or greater

- 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)

- A history of 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

- Patients with a score of > 28 on the Beck depression inventory consistent with severe

- Known hypersensitivity to armodafinil or related compounds

- Patients who have been receiving MAO inhibitors during the past 14 days

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Outcome Measure:

To estimate the difference between the two groups in treatment of fatigue in patients with malignant gliomas undergoing radiotherapy.

Outcome Time Frame:

8 weeks

Safety Issue:


Principal Investigator

Eudocia Lee, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Institutional Review Board

Study ID:




Start Date:

September 2008

Completion Date:

June 2014

Related Keywords:

  • Malignant Glioma
  • armodafinil
  • Nuvigil
  • fatigue
  • Fatigue
  • Glioma



Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756
UCSD San DiegoLa Jolla, California