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 range
18 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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)