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

Fatigue Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02385656
• Other study ID #: B-1302/191-003
• Status: Recruiting
• Phase: Phase 4
• First received: March 2, 2015
• Last updated: March 10, 2015
• Start date: March 2013
• Est. completion date: February 2016

Study information

• Verified date: March 2015
• Source: Seoul National University Bundang Hospital
• Contact: Hye youn Park, M.D.
• Phone: +82-10-8010-0815
• Email: hypark[@]snubh.org
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fatigue

Intervention

Drug:
• Modafinil
200mg of modafinil daily for 4 weeks

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	severity of fatigue (Brief Fatigue Inventory)	Brief Fatigue Inventory	4 weeks	No