Assessing the Efficacy of Immediate Release Methylphenidate, Sustained Release Methylphenidate and Modafinil for Patients With Brain Tumors
18 Years
N/A
Both
Brain Tumor
Trial Information
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
another one.
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.
Inclusion Criteria:
1. Patient diagnosed with a brain tumor, either primary or metastatic
2. Patient had prior radiation treatment to the brain
3. Patient is > or = 18 years of age
4. Patient has a Karnofsky performance status (KPS) performance of 70 at baseline
5. Patient is using acceptable birth control methods. Female participants (if of child
bearing age and sexually active) and male participants (if sexually active with a
partner of child-bearing potential) must use medically acceptable methods of birth
control, including abstinence, birth control pills, diaphragm with spermicide, condom
with foam or spermicide, vaginal spermicidal suppository or surgical sterilization.
6. Patient must speak and understand English or Spanish
7. Patient has reported cognitive decline and is being considered for stimulant therapy
by their neurologist
8. Patient has provided written informed consent to participate in the study prior to
enrollment to the study
Exclusion Criteria:
1. History of hypersensitivity reaction to methylphenidate or modafinil
2. History of severe headaches, glaucoma, major psychiatric diagnosis, narcolepsy,
Tourette's syndrome, marked anxiety, tension or agitation
3. History of clinically significant pulmonary or cardiac disease
4. Uncontrolled hypertension: has not been on a stable treatment dose for the past
month, or has a systolic pressure consistently greater than 140 mm Hg or diastolic
pressure consistently greater than 90 mm Hg
5. Patients with uncontrolled seizures will be excluded
6. Current use of illicit drugs or history of alcohol or drug abuse and/or abuse
potential
7. Moderate to severe depression (> 20 on Beck Depression Inventory II)
8. If taking antidepressants, patient must be on a stable dose
9. Currently taking psychostimulants, Monoamine oxidase (MAO) inhibitors, or
anticoagulants
10. Current use of the following herbals or supplements for fatigue relief
(dehydroepiandrosterone (DHEA), S-Adenosyl methionine (SAME), ginkgo, ginseng, St.
John's Wort)
11. Any coexisting medical condition or are taking any concomitant medication that is
likely to interfere with the safe administration of methylphenidate. Any potential
interactions or coexisting medical condition not specified by the protocol will be
determined by the prescribing physician as being exclusionary or not.
12. Patients currently taking any erythropoietin type drugs
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Mean Processing Speed Change From Baseline in the Trail-making Test Part A Score
Outcome Description:
'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).
Outcome Time Frame:
Baseline to 4-5 weeks on study medication
Safety Issue:
No
Principal Investigator
Jeffrey S. Wefel, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
M.D. Anderson Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
2003-0925
NCT ID:
NCT00418691
Start Date:
February 2004
Completion Date:
November 2009
Related Keywords:
- Brain Tumor
- Brain Tumor
- Methylphenidate
- Ritalin
- Modafinil
- Provigil
- Fatigue
- Concentration
- Brain Neoplasms
Name | Location |
|---|---|
| U.T.M.D. Anderson Cancer Center | Houston, Texas 77030 |
