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Pilot Study of Modafinil for Treatment of Fatigue in Cancer Patients
Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information
Alternate Title
Modafinil in Treating Fatigue in Patients With Cancer
Basic Trial Information
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Protocol IDs
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No phase specified
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Supportive care
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Closed
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18 and over
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NCI
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UVACC-HIC-10951
UVACC-30603, NCT00112515
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Objectives Primary - Determine the safety of modafinil in cancer patients.
- Determine the efficacy of this drug, in terms of improving fatigue, in these patients.
Secondary - Determine the efficacy of this drug, in terms of improving mood, cognitive ability, functional status, and quality of life, in these patients.
Entry Criteria Disease Characteristics:
- Diagnosis of cancer
- Brief Fatigue Inventory score ≥ 4
Prior/Concurrent Therapy:
Biologic therapy - Concurrent thalidomide allowed
Chemotherapy Endocrine therapy Radiotherapy Surgery Other - Concurrent narcotics, phenothiazines, or benzodiazepines allowed
- No other concurrent investigational therapy
Patient Characteristics:
Age Performance status Life expectancy Hematopoietic Hepatic Renal Cardiovascular - No history of left ventricular hypertrophy
- No history of ischemic ECG changes
- No history of chest pain
- No history of arrhythmia
- No history of other clinically significant manifestations of mitral valve prolapse in association with CNS stimulant use
Other - Not pregnant or nursing
- Negative pregnancy test
- Thyroid stimulating hormone normal
- No known hypersensitivity to modafinil
- No history of psychotic disorder and/or active psychosis
- No history of any chronic medical or psychiatric condition or laboratory abnormality that would preclude study participation or compliance
Expected Enrollment A total of 26 patients will be accrued for this study within 9 months. Outcomes Primary Outcome(s)Safety, in terms of adverse events and dose-limiting toxicity, as measured by NCI CTC v2.0 at up to 4 weeks after the start of treatment
Fatigue as measured by Brief Fatigue Inventory at 2 and 4 weeks after the start of treatment
Secondary Outcome(s)Mood as measured by Hamilton Rating Scale for Depression at 2 and 4 weeks after the start of treatment
Cognitive ability (i.e., memory, fine motor control, fluency, general mental ability, & delayed memory) by Hopkins Verbal Learning Test at 2 and 4 weeks after start of treatment
Cognitive ability (i.e., memory, fine motor control, fluency, general mental ability, & delayed memory) by Grooved Pegboard Test at 2 and 4 weeks after start of treatment
Cognitive ability (i.e., memory, fine motor control, fluency, general mental ability, & delayed memory) by Controlled Oral Word Association Test from the Multilingual Aphasia Examination at 2 and 4 weeks after start of treatment
Cognitive ability (i.e., memory, fine motor control, fluency, general mental ability, & delayed memory) by Trail Making Test A and B at 2 and 4 weeks after start of treatment
Cognitive ability (i.e., memory, fine motor control, fluency, general mental ability, & delayed memory) by Recall and Recognition of Word List encoded from the Hopkins Verbal Learning Test at 2 and 4 weeks after start of treatment
Functional status as measured by Barthel Index and ECOG performance status at 2 and 4 weeks after the start of treatment
Quality of life as measured by Functional Assessment of Cancer Therapy-Br at 2 and 4 weeks after the start of treatment
Outline This is a nonrandomized, pilot study. Patients receive oral modafinil once daily for 4 weeks in the absence of disease progression or unacceptable toxicity. Patients may receive additional modafinil at the discretion of the physician. Fatigue, mood, cognition, functional status, and quality of life are assessed at baseline and in weeks 2 and 4. After completion of study treatment, patients are followed at 30 days.
Trial Contact Information
Trial Lead Organizations University of Virginia Cancer Center | | | | Leslie Blackhall, MD, Principal investigator | | | |
| Registry Information | | | Official Title | | Pilot Study Evaluating the Safety and Efficacy of Modafinil in Improving Fatigue, Mood, Cognitive Ability, Functional Status, and Quality of Life of Cancer Patients | | | Trial Start Date | | 2004-02-03 | | | Registered in ClinicalTrials.gov | | NCT00112515 | | | Date Submitted to PDQ | | 2005-04-29 | | | Information Last Verified | | 2006-05-02 | | | NCI Grant/Contract Number | | CA44579 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.  Back to Top |
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