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About
RATIONALE: Armodafinil may help relieve fatigue and improve quality of life in patients with cancer receiving radiation therapy to the brain.
PURPOSE: This clinical trial is studying how well armodafinil works in treating fatigue caused by radiation therapy in patients with primary brain tumors.
Full description
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to therapy (radiotherapy alone vs radiotherapy and chemotherapy) and Karnofsky performance status (60-80% vs 90-100%). Patients are randomized to 1 of 2 arms.
Patients complete questionnaires assessing fatigue, quality of life, and neurocognitive function at baseline and periodically during study.
Enrollment
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Inclusion and exclusion criteria
Inclusion Criteria
Histologically confirmed primary brain tumor, including any of the following:
Planning to undergo external-beam cranial radiotherapy (partial- or whole-brain radiotherapy) meeting all of the following criteria:
PATIENT CHARACTERISTICS:
Karnofsky performance status 60-100%
Hemoglobin ≥ 10.0 g/dL (erythropoietin or transfusion allowed for symptomatically anemic patients with a hemoglobin < 10 g/dL)
Creatinine ≤ 2 mg/dL
Total bilirubin ≤ 2 times upper limit of normal (ULN)
SGOT and SGPT ≤ 3 times ULN
Not pregnant or nursing
Negative pregnancy test
Sexually active women of childbearing potential must use a reliable method of birth control
Prior malignancies allowed
Exclusion Criteria:
No baseline headaches (i.e., headaches occurring in the week before baseline assessment) of grade 4 severity (defined as severe and disabling headaches, requiring analgesics, and interfering with and preventing function or activities of daily living)
No concurrent uncontrolled illness that may cause fatigue; interfere with drug absorption, distribution, metabolism, or excretion; or limit compliance with study requirements including, but not limited to, any of the following:
Patients with a history of cardiac issues (symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia) should not use armodafinil as it may cause chest pain, palpitations, dyspnea, and transient ischemic T-wave changes on ECG
No history of allergic reaction attributed to modafinil or armodafinil
No anticipated or planned excessive consumption of coffee, tea, and/or caffeine-containing beverages averaging > 600 mg of caffeine/day (i.e., approximately 6 cups of coffee/day, 12 cups of hot tea/day, or 12 cans of cola/day)
PRIOR CONCURRENT THERAPY:
See Disease Characteristics
No prior fractionated external-beam cranial radiotherapy
More than 30 days since prior monoamine oxidate inhibitors or investigational drugs
More than 2 weeks since prior and no concurrent modafinil (Provigil), donepezil (Aricept), memantine hydrochloride (Namenda), methylphenidate (Ritalin), dextroamphetamine-amphetamine (Adderall), ginkgo biloba, or any other cognitive function-enhancing drugs
At least 4 weeks since prior and no concurrent interstitial or intracavitary chemotherapy and/or radiotherapy or stereotactic radiosurgery (i.e., Gamma Knife, Linac, or Cyberknife)
No concurrent erythropoietin, transfusion, or iron therapy (unless patient is symptomatically anemic with hemoglobin < 10 g/dL)
Concurrent chemotherapy allowed
Concurrent hormonal therapy for other malignancies allowed
No concurrent clopidogrel bisulfate (Plavix)
Primary purpose
Allocation
Interventional model
Masking
54 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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