Fatigue
Conditions
Brief summary
Open-pilot study for the efficacy and tolerability of modafinil on the fatigue and somnolence in cancer-patients.
Detailed description
This is an open-pilot study for the efficacy and tolerability of modafinil on the fatigue and somnolence in cancer-patients. Patients with moderate to severe cancer-related fatigue will be treated with modafinil for 4 weeks and psychological tests including self-questionnaire, cognitive test, sleep-wake cycle, quantitative electroencephalogram(QEEG) will be applied pre- and post-treatment.
Interventions
DRUGModafinil
200mg of modafinil daily for 4 weeks
Sponsors
Seoul National University Bundang Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* solid cancer patient * age of 20-65 years old * subjects who scored =4 or \>4 on the Brief Fatigue Inventory * subjects with informed consent
Exclusion criteria
* metastatic cancer(stage IV) * with psychotic symptoms such as delusion and hallucination or with suicidal risk * with delirium or dementia * current medication of cognitive enhancer or psychostimulant uncontrolled medical illness * current medications that are contraindicated or not recommended for co-administration with modafinil
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| severity of fatigue (Brief Fatigue Inventory) | 4 weeks | Brief Fatigue Inventory |
Countries
South Korea
Contacts
Primary ContactHye youn Park, M.D.
Outcome results
None listed