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

Seoul National University Bundang Hospital20 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Fatigue

Interventions

ModafinilDRUG

200mg of modafinil daily for 4 weeks

Eligibility

Sex: ALLMin age: 20 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

RECRUITING

Outcomes

Primary Outcomes

severity of fatigue (Brief Fatigue Inventory)

Brief Fatigue Inventory

Time frame: 4 weeks

Central Contacts

Hye youn Park, M.D.

CONTACT

+82-10-8010-0815 hypark@snubh.org

Data from ClinicalTrials.gov

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