Pilot Study Evaluating the Safety and Efficacy of Modafinil in Improving Fatigue, Mood, Cognitive Ability, Functional Status, and Quality of Life of Cancer Patients
18 Years
N/A
Both
Cognitive/Functional Effects, Depression, Fatigue, Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
Pilot Study Evaluating the Safety and Efficacy of Modafinil in Improving Fatigue, Mood, Cognitive Ability, Functional Status, and Quality of Life of Cancer Patients
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.
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.
PROJECTED ACCRUAL: A total of 26 patients will be accrued for this study within 9 months.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of cancer
- Brief Fatigue Inventory score ≥ 4
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 1-3
Life expectancy
- At least 2 months
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
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
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Concurrent thalidomide allowed
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Other
- Concurrent narcotics, phenothiazines, or benzodiazepines allowed
- No other concurrent investigational therapy
Type of Study:
Interventional
Study Design:
Primary Purpose: Supportive Care
Outcome Measure:
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
Principal Investigator
Leslie Blackhall, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Virginia
Authority:
United States: Federal Government
Study ID:
CDR0000432953
NCT ID:
NCT00112515
Start Date:
February 2004
Completion Date:
Related Keywords:
- Cognitive/Functional Effects
- Depression
- Fatigue
- Unspecified Adult Solid Tumor, Protocol Specific
- depression
- cognitive/functional effects
- fatigue
- unspecified adult solid tumor, protocol specific
- Depression
- Depressive Disorder
- Fatigue
Name | Location |
|---|---|
| University of Virginia Cancer Center | Charlottesville, Virginia 22908 |
