Effects of Methylphenidate Versus Sustained Release Methylphenidate on Cognitive Functioning - Full Text View

Sponsor:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00418691

Purpose

Primary Objective:

To assess the efficacy of immediate release methylphenidate, sustained release methylphenidate, and the novel vigilance enhancing drug modafinil for the improvement of cognitive functioning in patients with brain tumors.

Condition	Intervention	Phase
Brain Tumor	Drug: IR Methylphenidate Drug: Modafinil Drug: SR Methylphenidate	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Assessing the Efficacy of Immediate Release Methylphenidate, Sustained Release Methylphenidate and Modafinil for Patients With Brain Tumors

Resource links provided by NLM:

MedlinePlus related topics: Brain Cancer Cancer

Drug Information available for: Modafinil Methylphenidate Methylphenidate hydrochloride

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

Mean Processing Speed Change From Baseline in the Trail-making Test Part A Score [ Time Frame: Baseline to 4-5 weeks on study medication ] [ Designated as safety issue: No ]
'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).
Patient Cognitive Test Scores at End of Treatment Period [ Time Frame: Baseline to end of Week 4 treatment period ] [ Designated as safety issue: No ]
For cognitive assessment, set of widely used standardized psychometric instruments shown to be sensitive to neurotoxic effects of cancer treatment. Measures assess attention span (Digit Span), graphomotor speed (Digit Symbol), memory (Hopkins Verbal Memory Test-Revised), verbal fluency (Controlled Oral Words Association), visual motor scanning speed (Trail Making Test Part A), executive function (Trail Making Test Part B); motor speed and dexterity (Grooved Pegboard).

Enrollment:	34
Study Start Date:	February 2004
Study Completion Date:	November 2009
Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Immediate Release (IR) Methylphenidate 10 mg by mouth (PO) twice daily for 4 Weeks	Drug: IR Methylphenidate 10 mg by mouth (PO) twice daily x 4 Weeks Other Name: Ritalin
Active Comparator: Sustained Release (SR) Methylphenidate 200 mg PO once daily for 4 Weeks	Drug: SR Methylphenidate 18 mg PO Once Daily x 4 Weeks Other Name: Ritalin
Active Comparator: Modafinil 18 mg PO once daily for 4 Weeks	Drug: Modafinil 200 mg PO Once Daily x 4 Weeks Other Name: Provigil

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patient diagnosed with a brain tumor, either primary or metastatic
Patient had prior radiation treatment to the brain
Patient is > or = 18 years of age
Patient has a Karnofsky performance status (KPS) performance of 70 at baseline
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.
Patient must speak and understand English or Spanish
Patient has reported cognitive decline and is being considered for stimulant therapy by their neurologist
Patient has provided written informed consent to participate in the study prior to enrollment to the study

Exclusion Criteria:

History of hypersensitivity reaction to methylphenidate or modafinil
History of severe headaches, glaucoma, major psychiatric diagnosis, narcolepsy, Tourette's syndrome, marked anxiety, tension or agitation
History of clinically significant pulmonary or cardiac disease
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
Patients with uncontrolled seizures will be excluded
Current use of illicit drugs or history of alcohol or drug abuse and/or abuse potential
Moderate to severe depression (> 20 on Beck Depression Inventory II)
If taking antidepressants, patient must be on a stable dose
Currently taking psychostimulants, Monoamine oxidase (MAO) inhibitors, or anticoagulants
Current use of the following herbals or supplements for fatigue relief (dehydroepiandrosterone (DHEA), S-Adenosyl methionine (SAME), ginkgo, ginseng, St. John's Wort)
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.
Patients currently taking any erythropoietin type drugs

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00418691

Locations

United States, Texas
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Jeffrey S. Wefel, PhD

M.D. Anderson Cancer Center

More Information

Additional Information:

UT MD Anderson Cancer Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Jeffrey S. Wefel, PhD/Assistant Professor, U.T.M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00418691 History of Changes
Other Study ID Numbers:	2003-0925
Study First Received:	January 3, 2007
Results First Received:	January 10, 2011
Last Updated:	June 10, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Brain Tumor
Methylphenidate
Ritalin
Modafinil

Provigil
Fatigue
Concentration

Additional relevant MeSH terms:

Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Methylphenidate
Modafinil
Dopamine Uptake Inhibitors

Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on February 09, 2012