Phase 2
Completed N=54
Armodafinil in Treating Fatigue Caused By Radiation Therapy in Patients With Primary Brain Tumors
brain tumor · Nervous System Tumors · Cognition Disorders · Fatigue
Source: ClinicalTrials.gov NCT01032200 ↗
Enrolled (actual)
54
Serious AEs
34.0%
Results posted
Feb 2017
Primary outcomePrimary: Retention — 85; 75 percentage of participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Retention |
85; 75 | — |
| PRIMARY Adherence |
92.6; 95.7 | — |
| SECONDARY Fatigue |
32.4; 36.4 | — |
| SECONDARY Sleepiness |
7.2; 8.3 | — |
| SECONDARY HVLT-IR |
21.2; 20.0 | — |
Eligibility Criteria
Inclusion Criteria
- Histologically confirmed primary brain tumor, including any of the following:
- Glioblastoma multiforme
- Anaplastic astrocytoma
- Anaplastic oligodendroglioma
- Anaplastic mixed oligoastrocytoma
- Low-grade glioma
- Meningioma
- Ependymoma
- Other primary brain tumor histologies
- Planning to undergo external-beam cranial radiotherapy (partial- or whole-brain radiotherapy) meeting all of the following criteria:
- Total dose ≥ 4,500 cGy
- Total number of fractions ≥ 25 fractions
- Dose per fraction ≥ 150 cGy
PATIENT CHARACTERISTICS:
- Karnofsky performance status 60-100%
- Hemoglobin ≥ 10.0 g/dL (erythropoietin or transfusion allowed for symptomatically anemic patients with a hemoglobin 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 non-hormonal therapy (e.g., Herceptin and other targeted agents), or cytotoxic chemotherapy
- No concurrent clopidogrel bisulfate (Plavix)
Data sourced from ClinicalTrials.gov (NCT01032200). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.