Assessing the Efficacy of Immediate Release Methylphenidate, Sustained Release Methylphenidate and Modafinil for Patients With Brain Tumors
All three drugs used in this clinical research study are widely used stimulants to help
cancer patients who have fatigue and problems with concentration.
Before treatment starts, you will have a physical exam, including measurement of blood
pressure, and neuropsychological and symptom evaluations. The neuropsychological evaluation
is made up of tests of attention, memory, speech, and other brain functions, and takes about
30 minutes to complete. The other test evaluates symptoms you may be experiencing, such as
fatigue or depression, and takes about 10 minutes to complete.
You will be randomly assigned (as in the toss of a coin) to one of three treatment groups.
Participants in the first group will receive Immediate Release (IR) methylphenidate.
Participants in the second group will receive Sustained Release (SR) methylphenidate.
Participants in the third group will receive modafinil. There is an equal chance of being
assigned to any of the groups. After you are randomized, you will contact the M. D.
Anderson pharmacy to receive your assigned medication. You will receive a total of 5 weeks
worth of medication. The extra week of medication is to allow for buffer should there be
any conflict in rescheduling the follow-up evaluation.
IR methylphenidate is a pill taken twice a day. Both SR methylphenidate and modafinil are
pills taken once a day. The amount of the medicine is the same for all three groups. You
will take the medication every day for a total of 4 weeks.
You will be asked to complete a study calendar, which will be provided by the research
staff. In the study calendar, you will be asked to initial after you take the study drug
each day, and to record any side effects you may experience. You will be required to return
the completed study calendar at the final evaluation visit, along with the empty bottles and
any of the study drugs that may be left over.
You will remain on treatment for 4 weeks and return for a final evaluation. A follow-up
neuropsychological evaluation and evaluation of symptoms will be performed. At the end of
the study treatment period, you will be allowed to remain on active treatment if you wish
to. You can discuss with your doctor whether to continue on the same medication or to try
This is an investigational study. All of the study drugs are FDA approved and currently are
used to help brain tumor patients. A total of 75 patients will take part in this study. All
will be enrolled at M. D. Anderson.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Mean Processing Speed Change From Baseline in the Trail-making Test Part A Score
'Trail Making Test Part A' is a neuropsychological test of visual attention and task switching, administered to measure processing speed, timed as participants follow "trail" made by consecutive numbers (1,2,3, etc.). The test is finished as quickly as possible, and the time taken to complete the test used as the primary performance metric (in seconds). Maximum time allowed is 300 seconds. A lower change score indicates improvement. Participants tested before starting study medication and 4-5 weeks later while on study medication, reflected in a z score (deviations from population mean).
Baseline to 4-5 weeks on study medication
Jeffrey S. Wefel, PhD
M.D. Anderson Cancer Center
United States: Institutional Review Board
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