The Efficacy and Tolerability of Modafinil for Fatigue and Daytime Sleepiness in Cancer Patients: Preliminary Study

• Status: Unknown status
• Trial end date: 2016-02-01
• Target enrollment: 0
• Participant gender: All

Summary

Open-pilot study for the efficacy and tolerability of modafinil on the fatigue and somnolence in cancer-patients.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Bundang Hospital
• Treatments: Armodafinil; Modafinil

Criteria

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