Clinical trial NCT00766467: A Randomized Placebo-Controlled Trial of Armodafinil (Nuvigil) for Fatigue in Patients With Malignant Gliomas
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Malignant Glioma
Keywords: armodafinil
Nuvigil
fatigue
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Dartmouth-Hitchcock Medical Center
name: University of California, San Diego
name: Beth Israel Deaconess Medical Center
name: Cephalon
First posted: 2008-10-06
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in Fatigue at Day 43
timeFrame: 43 days
Secondary outcomes:
measure: Change From Baseline in Quality of Life at Days 22, 43 and 56
timeFrame: baseline, day 22, day 43, and day 56
measure: Number of Grade 3-4 Side Effects at Least Possibly Related to Study Treatment
timeFrame: 56 days
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UCSD San Diego
state: California
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Eudocia Lee, MD
role: PRINCIPAL_INVESTIGATOR
References: