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

March 10, 2015 updated by: In-Young Yoon, Seoul National University Bundang Hospital
Open-pilot study for the efficacy and tolerability of modafinil on the fatigue and somnolence in cancer-patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, ASI|KR|KS009|SEONGNAM
        • Recruiting
        • Seoul National University Bundang Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
Subjects who take modafinil for cancer-related fatigue for 4 weeks.
Drug: Modafinil
200mg of modafinil daily for 4 weeks
Other Names:
  • Provigil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
severity of fatigue (Brief Fatigue Inventory)
Time Frame: 4 weeks
Brief Fatigue Inventory
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Bundang Hospital

Investigators

  • Principal Investigator: Inyoung Yoon, M.D., Ph.D., Department of Psychiatry, Seoul National University Bundang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Anticipated)

February 1, 2016

Study Completion (Anticipated)

February 1, 2016

Study Registration Dates

First Submitted

March 2, 2015

First Submitted That Met QC Criteria

March 10, 2015

First Posted (Estimate)

March 11, 2015

Study Record Updates

Last Update Posted (Estimate)

March 11, 2015

Last Update Submitted That Met QC Criteria

March 10, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B-1302/191-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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