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

This study has been completed.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center Identifier:
First received: January 24, 2003
Last updated: February 5, 2016
Last verified: February 2016

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 Intervention
Brain and Central Nervous System Tumors
Cognitive/Functional Effects
Drug: modafinil

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:

Further study details as provided by Jonsson Comprehensive Cancer Center:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 29
Study Start Date: September 2002
Study Completion Date: August 2010
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.


Ages Eligible for Study:   21 Years to 65 Years   (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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00052286

United States, California
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-6967
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Timothy F. Cloughesy, MD Jonsson Comprehensive Cancer Center
  More Information

Responsible Party: Jonsson Comprehensive Cancer Center Identifier: NCT00052286     History of Changes
Other Study ID Numbers: CDR0000258139
P30CA016042 ( US NIH Grant/Contract Award Number )
Study First Received: January 24, 2003
Last Updated: February 5, 2016

Keywords provided by Jonsson Comprehensive Cancer Center:
adult brain tumor
cognitive/functional effects

Additional relevant MeSH terms:
Nervous System Neoplasms
Central Nervous System Neoplasms
Signs and Symptoms
Neoplasms by Site
Nervous System Diseases
Wakefulness-Promoting Agents
Central Nervous System Stimulants
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs processed this record on May 25, 2017