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

Sponsors and Collaborators:	Dana-Farber Cancer Institute Beth Israel Deaconess Medical Center Massachusetts General Hospital Cephalon
Information provided by:	Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00766467

Purpose

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.

Condition	Intervention	Phase
Malignant Glioma	Drug: Armodafinil Other: Placebo	Phase II

MedlinePlus related topics: Cancer

Drug Information available for: Armodafinil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:

To estimate the difference between the two groups in treatment of fatigue in patients with malignant gliomas undergoing radiotherapy. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To assess the impact of armodafinil on quality of life in patients with malignant gliomas undergoing radiotherapy [ Time Frame: 2 years ] [ Designated as safety issue: No ]
To assess the effect of armodafinil on mood in this patient population [ Time Frame: 2 years ] [ Designated as safety issue: No ]
To assess the side effect profile of armodafinil in this patient population [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	70
Study Start Date:	September 2008
Estimated Study Completion Date:	July 2011
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group 1: Experimental Armodafinil	Drug: Armodafinil Taken orally once a day in the morning. Dose will change depending upon level of fatigue
Group 2: Placebo Comparator Placebo	Other: Placebo Placebo taken once a day in the morning

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 5 days from the radiation start date.
Participants will be evaluated in the physician's office on days 1, 8, 22, 43 and 57.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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
Life expectancy of six months or greater
Able to swallow medication

Exclusion Criteria:

History of cardiac arrhythmia or unstable angina
Has taken armodafinil or modafinil
Has taken a psychostimulant or a monoamine oxidase inhibitor on a regular basis within the past 30 days
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, uncontrolled hypertension, alcohol or drug abuse, severe headaches, glaucoma, narcolepsy, a 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 12 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 > 31 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00766467

Contacts

Contact: Jan Drappatz, MD

617-632-2166

Locations

United States, Massachusetts
Dana-Farber Cancer Institute	Recruiting
Boston, Massachusetts, United States, 02115
Principal Investigator: Jan Drappatz, MD
Beth Israel Deaconess Medical Center	Not yet recruiting
Boston, Massachusetts, United States, 02115
Principal Investigator: Eric Wong, MD
Massachusetts General Hospital	Not yet recruiting
Boston, Massachusetts, United States, 02114
Principal Investigator: April Eichler, MD

Sponsors and Collaborators

Dana-Farber Cancer Institute

Beth Israel Deaconess Medical Center

Massachusetts General Hospital

Cephalon

Investigators

Principal Investigator:

Jan Drappatz, MD

Dana-Farber Cancer Institute

More Information

Responsible Party:	Dana-Farber Cancer Institute ( Jan Drappatz, MD )
Study ID Numbers:	07-341
Study First Received:	October 2, 2008
Last Updated:	October 2, 2008
ClinicalTrials.gov Identifier:	NCT00766467
Health Authority:	United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:

armodafinil
Nuvigil
fatigue

Study placed in the following topic categories:

Neuroectodermal Tumors
Fatigue
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma

Glioma
Modafinil
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Therapeutic Uses
Physiological Effects of Drugs
Neoplasms, Nerve Tissue
Central Nervous System Stimulants

Neoplasms, Neuroepithelial
Protective Agents
Neuroprotective Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009