Brain TumorPhase 3NCT00418691
Effects of Methylphenidate Versus Sustained Release Methylphenidate on Cognitive Functioning
A Phase 3 study testing IR Methylphenidate, Modafinil and SR Methylphenidate in people with Brain Tumor, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Tumor
- What is being tested?
- IR Methylphenidate, Modafinil and SR Methylphenidate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2004to Nov 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
U.T.M.D. Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Assessing the Efficacy of Immediate Release Methylphenidate, Sustained Release Methylphenidate and Modafinil for Patients With Brain Tumors
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.
Read the 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.
- Conditions
- Brain Tumor
- Being tested
- IR Methylphenidate, Modafinil, SR Methylphenidate
- Keywords
- Brain Tumor, Methylphenidate, Ritalin, Modafinil, Provigil, Fatigue, Concentration
- Medical subject headings
- Brain Neoplasms, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IR MethylphenidateDrug
Also called Ritalin
10 mg by mouth (PO) twice daily x 4 Weeks
ModafinilDrug
Also called Provigil
200 mg PO Once Daily x 4 Weeks
SR MethylphenidateDrug
Also called Ritalin
18 mg PO Once Daily x 4 Weeks
| Study group | Role | What they receive |
|---|---|---|
| Immediate Release (IR) Methylphenidate | Active comparator | 10 mg by mouth (PO) twice daily for 4 Weeks Receives: Drug: IR Methylphenidate |
| Sustained Release (SR) Methylphenidate | Active comparator | 200 mg PO once daily for 4 Weeks Receives: Drug: SR Methylphenidate |
| Modafinil | Active comparator | 18 mg PO once daily for 4 Weeks Receives: Drug: Modafinil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline to 4-5 weeks on study medication
Patient Cognitive Test Scores at End of Treatment Period
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).
Measured: Baseline to end of Week 4 treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2007 (estimated)
- Study startFeb 2004
- Primary completionNov 2009
- Study completionNov 2009
Why it stopped: Closed early due to slow accrual.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Brain TumorStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeffrey S. Wefel, PhD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00418691
- Sponsor's protocol ID
- 2003-0925
- Status last verified
- Sep 2020
- First submitted
- 3 Jan 2007
- Last updated
- 23 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Efficacy of Immediate Release Methylphenidate, Sustained Release Methylphenidate and Modafinil for Patients With Brain Tumors
- ClinicalTrials.gov ID
- NCT00418691
- Acronym / sponsor ID
- 2003-0925
- Conditions
- Brain Tumor
- Keywords
- Brain Tumor, Methylphenidate, Ritalin, Modafinil, Provigil, Fatigue, Concentration
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Closed early due to slow accrual.
- Enrolment
- 34 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Feb 2004
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 5 Jan 2007 (estimated)
- Results
- Posted 6 May 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Immediate Release (IR) Methylphenidate | Active comparator | Drug: IR Methylphenidate10 mg by mouth (PO) twice daily for 4 Weeks |
| Sustained Release (SR) Methylphenidate | Active comparator | Drug: SR Methylphenidate200 mg PO once daily for 4 Weeks |
| Modafinil | Active comparator | Drug: Modafinil18 mg PO once daily for 4 Weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IR MethylphenidateAlso: Ritalin10 mg by mouth (PO) twice daily x 4 Weeks | Drug | Immediate Release (IR) Methylphenidate |
| ModafinilAlso: Provigil200 mg PO Once Daily x 4 Weeks | Drug | Modafinil |
| SR MethylphenidateAlso: Ritalin18 mg PO Once Daily x 4 Weeks | Drug | Sustained Release (SR) Methylphenidate |
Primary outcome
Mean Processing Speed Change From Baseline in the Trail-making Test Part A Score
Time frame: Baseline to 4-5 weeks on study medication
'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
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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- UT MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey S. Wefel, PhD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing IR Methylphenidate, Modafinil and SR Methylphenidate in people with Brain Tumor, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 May 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Processing Speed Change From Baseline in the Trail-making Test Part A Score (time frame: Baseline to 4-5 weeks on study medication). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2020.