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

Primary Purpose

Fatigue

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Modafinil
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fatigue

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Seoul National University Bundang HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention group

Arm Description

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

Outcomes

Primary Outcome Measures

severity of fatigue (Brief Fatigue Inventory)
Brief Fatigue Inventory

Secondary Outcome Measures

Full Information

First Posted
March 2, 2015
Last Updated
March 10, 2015
Sponsor
Seoul National University Bundang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02385656
Brief Title
The Efficacy and Tolerability of Modafinil for Fatigue and Daytime Sleepiness in Cancer Patients: Preliminary Study
Official Title
The Efficacy and Tolerability of Modafinil for Fatigue and Daytime Sleepiness in Cancer Patients: Preliminary Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Unknown status
Study Start Date
March 2013 (undefined)
Primary Completion Date
February 2016 (Anticipated)
Study Completion Date
February 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Subjects who take modafinil for cancer-related fatigue for 4 weeks.
Intervention Type
Drug
Intervention Name(s)
Modafinil
Other Intervention Name(s)
Provigil
Intervention Description
200mg of modafinil daily for 4 weeks
Primary Outcome Measure Information:
Title
severity of fatigue (Brief Fatigue Inventory)
Description
Brief Fatigue Inventory
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hye youn Park, M.D.
Phone
+82-10-8010-0815
Email
hypark@snubh.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Inyoung Yoon, M.D., Ph.D.
Organizational Affiliation
Department of Psychiatry, Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
ASI|KR|KS009|SEONGNAM
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hye youn Park, M.D.
Phone
+82-10-8010-0815
Email
hypark@snubh.org

12. IPD Sharing Statement

Learn more about this trial

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

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