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Sponsors and Collaborators: |
Dana-Farber Cancer Institute Beth Israel Deaconess Medical Center Cephalon |
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Information provided by: | Dana-Farber Cancer Institute |
ClinicalTrials.gov Identifier: | NCT00766467 |
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 |
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 |
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
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Drug: Armodafinil
Taken orally once a day in the morning. Dose will change depending upon level of fatigue
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Group 2: Placebo Comparator
Placebo
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Other: Placebo
Placebo taken once a day in the morning
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Neither the participant or the study doctor will know what group they are in.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jan Drappatz, MD | 617-632-2166 |
United States, Massachusetts | |
Dana-Farber Cancer Institute | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Principal Investigator: Jan Drappatz, MD | |
Beth Israel Deaconess Medical Center | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Principal Investigator: Eric Wong, MD |
Principal Investigator: | Jan Drappatz, MD | Dana-Farber Cancer Institute |
Responsible Party: | Dana-Farber Cancer Institute ( Jan Drappatz, MD ) |
Study ID Numbers: | 07-341 |
Study First Received: | October 2, 2008 |
Last Updated: | February 17, 2009 |
ClinicalTrials.gov Identifier: | NCT00766467 History of Changes |
Health Authority: | United States: Institutional Review Board |
armodafinil Nuvigil fatigue |
Neuroectodermal Tumors Fatigue Neoplasms, Germ Cell and Embryonal Neuroepithelioma Central Nervous System Stimulants |
Glioma Neuroprotective Agents Modafinil Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Neoplasms, Nerve Tissue Physiological Effects of Drugs Central Nervous System Stimulants Protective Agents Neuroprotective Agents Modafinil Pharmacologic Actions |
Neuroectodermal Tumors Neoplasms Therapeutic Uses Neoplasms, Germ Cell and Embryonal Glioma Neoplasms, Neuroepithelial Central Nervous System Agents Neoplasms, Glandular and Epithelial |