Armodafinil in Treating Fatigue Caused By Radiation Therapy in Patients With Primary Brain Tumors (NCT01032200) | Clinical Trial Compass
CompletedPhase 2
Armodafinil in Treating Fatigue Caused By Radiation Therapy in Patients With Primary Brain Tumors
United States54 participantsStarted 2010-08-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 \< 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
* It is recommended that patients use non-hormonal contraceptives, in addition to or in place of hormonal contraceptives, during and for one month following treatment with armodafinil
* 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…
What they're measuring
1
Retention
Timeframe: 4 weeks post-RT (approximately 3 months post randomization)
2
Adherence
Timeframe: 4 weeks post-RT (approximately 3 months post randomization)