The Efficacy and Tolerability of Modafinil for Fatigue and Daytime Sleepiness in Cancer Patients: Preliminary Study
- Registration Number
- NCT02385656
- Lead Sponsor
- Seoul National University Bundang Hospital
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 20
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intervention group Modafinil Subjects who take modafinil for cancer-related fatigue for 4 weeks.
- Primary Outcome Measures
Name Time Method severity of fatigue (Brief Fatigue Inventory) 4 weeks Brief Fatigue Inventory
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Gyeonggi-do, Korea, Republic of