Brain and Central Nervous System TumorsNCT00052286
Modafinil in Treating Fatigue and Behavioral Change in Patients With Primary Brain Cancer
A study testing modafinil in people with Brain and Central Nervous System Tumors and Cognitive/Functional Effects, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Modafinil may be effective in relieving fatigue and improving behavioral changes such as memory loss in patients who have undergone treatment for primary brain cancer. The effectiveness of modafinil in relieving fatigue and improving behavioral change is not yet known. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Brain and Central Nervous System Tumors, Cognitive/Functional Effects, Fatigue
- What is being tested?
- modafinil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2002to Aug 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of primary malignant brain tumor and receiving treatment in the UCLA Neuro-Oncology Program
- Nonmalignant cerebral tumors also allowed
- Received some combination of prior therapy for disease, including neurosurgical resection, radiotherapy, and cytotoxic or cytostatic chemotherapy
- Mild to severe fatigue and/or attention/memory impairment, as measured by the Clinical Global Impression of Severity Scale
- Age 21 to 65
- Able to speak English
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- Capable of completing self-rating scales and one-on-one psychometric tests
- Negative pregnancy test
- Fertile patients must use effective contraception
- Concurrent conventional chemotherapy (e.g., carboplatin, lomustine, temozolomide) allowed
- Concurrent glucocorticoids (e.g., dexamethasone) allowed
- Concurrent tamoxifen allowed
- At least 30 days since prior stimulants (e.g., amphetamines or methylphenidate)
- Concurrent anticonvulsants allowed
- Concurrent isotretinoin allowed
Who cannot join
- Have significant hepatic disease, defined as SGOT greater than or equal to 2.5 times the upper limit of normal.
- Have significant renal disease, defined as creatinine greater than or equal to 1.5mg/dl.
- severe cognitive impairment
- other terminal illness
- emergency patient
- institutional resident
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- prisoner or parolee
- UCLA students or staff
- pregnant or nursing
- concurrent irinotecan
- concurrent participation in UCLA experimental chemotherapy trials
- prior modafinil
- concurrent experimental anticancer medication
- concurrent tricyclic antidepressants and/or monoamine oxidase inhibitors
Trial locations and contacts
1 site in 1 country.
United States1 site
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, 90095-6967
About this study
Official title: A Pilot Study of Modafinil for Treatment of Fatigue and Neurobehavioral Dysfunction in Adult Brain Tumor Patients
RATIONALE: Modafinil may be effective in relieving fatigue and improving behavioral changes such as memory loss in patients who have undergone treatment for primary brain cancer. The effectiveness of modafinil in relieving fatigue and improving behavioral change is not yet known.
PURPOSE: This randomized clinical trial is comparing how well two different doses of modafinil work in treating fatigue and behavioral changes in patients who have undergone treatment for primary brain cancer.
Read the detailed description
OBJECTIVES:
- Compare the effectiveness of low-dose vs high-dose modafinil for treatment of fatigue and neurobehavioral dysfunction in patients with primary brain tumors.
- Determine the safety of this drug in these patients.
- Compare quality of life of patients treated with 2 different doses of this drug.
OUTLINE: This is a randomized, double-blind, parallel-group study. Patients are randomized to 1 of 2 arms.
- Randomized phase:
- Arm I: Patients receive oral high-dose modafinil twice daily.
- Arm II: Patients receive oral low-dose modafinil twice daily. In both arms, treatment in this phase continues for 3 weeks followed by a 1-week washout period.
- Extended treatment phase:After the 1-week washout period, all patients receive oral low-dose modafinil once daily on days 1-3. The dose is then titrated to an optimal level and administered in divided doses.
Fatigue, neurobehavioral dysfunction, and quality of life are assessed during the randomized phase at baseline and on days 7 and 21 and then during the extended treatment phase at baseline and on days 28 and 56.
PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study.
- Being tested
- modafinil
- Keywords
- adult brain tumor, fatigue, cognitive/functional effects
- Medical subject headings
- Central Nervous System Neoplasms, Fatigue, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modafinilDrug
| Study group | Role | What they receive |
|---|---|---|
| drug dosage 1 | Experimental | - Arm I: Patients receive oral high-dose modafinil twice daily. Receives: Drug: modafinil |
| drug dosage 2 | Experimental | - Arm II: Patients receive oral low-dose modafinil twice daily. Receives: Drug: modafinil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurocognitive functioning
Measured: at baseline and weeks 1, 3, 4, 8, and 10
Secondary outcomes (1)
Global functioning as assessed by Clinical Global Impression of Severity and Clinical Global Impression of Change.
Measured: at baseline and weeks 1, 3, 4, 5, 7, 8, 9, and 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startSep 2002
- Primary completionJul 2006
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain and Central Nervous System TumorsStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Cephalon
- Responsible party
- Sponsor
- Investigators
- Timothy F. Cloughesy, MD, Principal investigator, Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00052286
- Sponsor's protocol ID
- CDR0000258139
- Other IDs
- UCLA-0206017, CEPHALON-UCLA-0206017, NCI-G02-2133
- Status last verified
- Feb 2016
- First submitted
- 24 Jan 2003
- Last updated
- 3 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Modafinil for Treatment of Fatigue and Neurobehavioral Dysfunction in Adult Brain Tumor Patients
- ClinicalTrials.gov ID
- NCT00052286
- Acronym / sponsor ID
- CDR0000258139
- Keywords
- adult brain tumor, fatigue, cognitive/functional effects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Cephalon
- Study start
- Sep 2002
- Primary completion
- Jul 2006 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Modafinil may be effective in relieving fatigue and improving behavioral changes such as memory loss in patients who have undergone treatment for primary brain cancer. The effectiveness of modafinil in relieving fatigue and improving behavioral change is not yet known.
PURPOSE: This randomized clinical trial is comparing how well two different doses of modafinil work in treating fatigue and behavioral changes in patients who have undergone treatment for primary brain cancer.
Detailed description
OBJECTIVES:
- Compare the effectiveness of low-dose vs high-dose modafinil for treatment of fatigue and neurobehavioral dysfunction in patients with primary brain tumors.
- Determine the safety of this drug in these patients.
- Compare quality of life of patients treated with 2 different doses of this drug.
OUTLINE: This is a randomized, double-blind, parallel-group study. Patients are randomized to 1 of 2 arms.
- Randomized phase:
- Arm I: Patients receive oral high-dose modafinil twice daily.
- Arm II: Patients receive oral low-dose modafinil twice daily. In both arms, treatment in this phase continues for 3 weeks followed by a 1-week washout period.
- Extended treatment phase:After the 1-week washout period, all patients receive oral low-dose modafinil once daily on days 1-3. The dose is then titrated to an optimal level and administered in divided doses.
Fatigue, neurobehavioral dysfunction, and quality of life are assessed during the randomized phase at baseline and on days 7 and 21 and then during the extended treatment phase at baseline and on days 28 and 56.
PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| drug dosage 1 | Experimental | Drug: modafinil- Arm I: Patients receive oral high-dose modafinil twice daily. |
| drug dosage 2 | Experimental | Drug: modafinil- Arm II: Patients receive oral low-dose modafinil twice daily. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Diagnosis of primary malignant brain tumor and receiving treatment in the UCLA Neuro-Oncology Program
- Nonmalignant cerebral tumors also allowed
- Received some combination of prior therapy for disease, including neurosurgical resection, radiotherapy, and cytotoxic or cytostatic chemotherapy
- Mild to severe fatigue and/or attention/memory impairment, as measured by the Clinical Global Impression of Severity Scale
- Age 21 to 65
Key exclusion criteria (14 listed)
- Have significant hepatic disease, defined as SGOT greater than or equal to 2.5 times the upper limit of normal.
- Have significant renal disease, defined as creatinine greater than or equal to 1.5mg/dl.
- severe cognitive impairment
- other terminal illness
- emergency patient
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 |
|---|---|---|
| modafinil | Drug | drug dosage 1, drug dosage 2 |
Primary outcome
Neurocognitive functioning
Time frame: at baseline and weeks 1, 3, 4, 8, and 10
1 secondary outcome
Global functioning as assessed by Clinical Global Impression of Severity and Clinical Global Impression of Change.
Time frame: at baseline and weeks 1, 3, 4, 5, 7, 8, 9, and 10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2020.
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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.
Timothy F. Cloughesy, MD principal investigator
Jonsson Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing modafinil in people with Brain and Central Nervous System Tumors and Cognitive/Functional Effects, run by Jonsson Comprehensive 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 15 inclusion and 14 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: finished, as of the sponsor's last update on 3 Aug 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Neurocognitive functioning (time frame: at baseline and weeks 1, 3, 4, 8, and 10). 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 3 Aug 2020.