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

Seoul National University

Status and phase: Unknown; Phase 4

Conditions: Fatigue

Treatments: Drug: Modafinil

Study type: Interventional

Funder types: Other

Identifiers

NCT02385656

B-1302/191-003

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Intervention group

Experimental group

Description:

Subjects who take modafinil for cancer-related fatigue for 4 weeks.

Treatment:

Drug: Modafinil