Modafinil in Treating Fatigue and Behavioral Change in Patients With Primary Brain Cancer
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Brain and Central Nervous System Tumors; Cognitive/Functional Effects; Fatigue
Intervention: modafinil (Drug)
Phase: N/A
Status: Active, not recruiting
Sponsored by: Jonsson Comprehensive Cancer Center Official(s) and/or principal investigator(s):
Timothy F. Cloughesy, MD, Principal Investigator, Affiliation: Jonsson Comprehensive Cancer Center
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.
Clinical Details
Official title: A Pilot Study of Modafinil for Treatment of Fatigue and Neurobehavioral Dysfunction in Adult Brain Tumor Patients
Study design: Supportive Care, Randomized, Double-Blind, Active Control
Primary outcome: Neurocognitive functioning as assessed by Trail Making Test, Symbol Digit Modalities Test, and Verbal Fluency at baseline and weeks 1, 3, 4, 8, and 10Mood as assessed by Hamilton Depression Scale (31 questions) at baseline and weeks 3, 4, 8, and 10 Fatigue level as assessed by Fatigue Severity Scale, Modified Fatigue Impact Scale, and Visual Analogue Fatigue Scale at baseline and weeks 1, 3, 4, 5, 7, 8, 9, and 10
Secondary outcome: Global functioning as assessed by Clinical Global Impression of Severity and Clinical Global Impression of Change at baseline and weeks 1, 3, 4, 5, 7, 8, 9, and 10
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.
Eligibility
Minimum age: 21 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
DISEASE CHARACTERISTICS:
- 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
PATIENT CHARACTERISTICS:
Age
- 21 to 65
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Bilirubin no greater than 2. 5 times normal
- SGOT no greater than 2. 5 times normal
Renal
- Creatinine no greater than 1. 5 mg/dL
Other
- Able to speak English
- Capable of completing self-rating scales and one-on-one psychometric tests
- No severe cognitive impairment
- No other terminal illness
- No emergency patients
- No institutional residents
- No prisoners or parolees
- No UCLA students or staff
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- See Disease Characteristics
- No concurrent irinotecan
- No concurrent participation in UCLA experimental chemotherapy trials
- Concurrent conventional chemotherapy (e. g., carboplatin, lomustine, temozolomide)
allowed
Endocrine therapy
- Concurrent glucocorticoids (e. g., dexamethasone) allowed
- Concurrent tamoxifen allowed
Radiotherapy
- See Disease Characteristics
Surgery
- See Disease Characteristics
Other
- No prior modafinil
- At least 30 days since prior stimulants (e. g., amphetamines or methylphenidate)
- No concurrent experimental anticancer medication
- No concurrent tricyclic antidepressants and/or monoamine oxidase inhibitors
- Concurrent anticonvulsants allowed
- Concurrent isotretinoin allowed
Locations and Contacts
Jonsson Comprehensive Cancer Center at UCLA, Los Angeles, California 90095-6967, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: September 2002
Last updated: May 23, 2008
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