Cognitive/Functional Effects, Depression, Fatigue, Unspecified Adult Solid Tumor, Protocol Specific
Conditions
Keywords
depression, cognitive/functional effects, fatigue, unspecified adult solid tumor, protocol specific
Brief summary
RATIONALE: Modafinil may help relieve fatigue and improve quality of life in patients with cancer. PURPOSE: This clinical trial is studying how well modafinil works in treating fatigue in patients with cancer.
Detailed description
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.
Interventions
DRUGmodafinil
PROCEDUREcognitive assessment
PROCEDUREpsychosocial assessment and care
PROCEDUREquality-of-life assessment
Sponsors
National Cancer Institute (NCI)
University of Virginia
Study design
Primary purpose
SUPPORTIVE_CARE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
| Mood as measured by Hamilton Rating Scale for Depression at 2 and 4 weeks after the 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 | — |
| 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 | — |
| 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 | — |
Countries
United States
Outcome results
None listed