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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00766467
• Other study ID #: 07-341
• Status: Completed
• Phase: Phase 2
• First received: October 2, 2008
• Last updated: April 27, 2015
• Start date: September 2008
• Est. completion date: July 2014

Study information

• Verified date: April 2015
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Glioma
• Malignant Glioma

Intervention

Drug:
• Armodafinil
Taken orally once a day in the morning. Dose will change depending upon level of fatigue

Other:
• Placebo
Placebo taken once a day in the morning

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	UCSD San Diego	La Jolla	California
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire

Sponsors (5)

Lead Sponsor	Collaborator
Eudocia Quant Lee, MD	Beth Israel Deaconess Medical Center, Cephalon, Dartmouth-Hitchcock Medical Center, University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To estimate the difference between the two groups in treatment of fatigue in patients with malignant gliomas undergoing radiotherapy.		8 weeks	No
Secondary	To assess the impact of armodafinil on quality of life in patients with malignant gliomas undergoing radiotherapy		8 weeks	No
Secondary	To assess the effect of armodafinil on mood in this patient population		8 weeks	No
Secondary	To assess the side effect profile of armodafinil in this patient population		8 weeks	Yes