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Modafinil in Treating Fatigue and Behavioral Change in Patients With Primary Brain Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00052286
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : August 3, 2020
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

Brief 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.

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.

Condition or disease Intervention/treatment Phase
Brain and Central Nervous System Tumors Cognitive/Functional Effects Fatigue Drug: modafinil Not Applicable

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Official Title: A Pilot Study of Modafinil for Treatment of Fatigue and Neurobehavioral Dysfunction in Adult Brain Tumor Patients
Study Start Date : September 2002
Actual Primary Completion Date : July 2006
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Modafinil

Arm Intervention/treatment
Experimental: drug dosage 1
- Arm I: Patients receive oral high-dose modafinil twice daily.
Drug: modafinil
Experimental: drug dosage 2
- Arm II: Patients receive oral low-dose modafinil twice daily.
Drug: modafinil

Primary Outcome Measures :
  1. Neurocognitive functioning [ Time Frame: at baseline and weeks 1, 3, 4, 8, and 10 ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00052286

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United States, California
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-6967
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
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Principal Investigator: Timothy F. Cloughesy, MD Jonsson Comprehensive Cancer Center
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Responsible Party: Jonsson Comprehensive Cancer Center Identifier: NCT00052286    
Other Study ID Numbers: CDR0000258139
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: August 3, 2020
Last Verified: February 2016
Keywords provided by Jonsson Comprehensive Cancer Center:
adult brain tumor
cognitive/functional effects
Additional relevant MeSH terms:
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Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms by Site
Nervous System Diseases
Central Nervous System Stimulants
Physiological Effects of Drugs
Wakefulness-Promoting Agents
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action