The Efficacy and Tolerability of Modafinil for Fatigue an... | NCT02385656

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

NCT02385656

Sponsor

Seoul National University Bundang Hospital

Status

Unknown status

Last Update Posted

Mar 11, 2015Estimated

Enrollment

20Estimated

Phase

Phase 4

Conditions

Fatigue

Interventions

Modafinil

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2013

Primary Completion Date

Feb 2016Estimated

Completion Date

Feb 2016Estimated

First Submitted Date

Mar 2, 2015

First Submission Date that Met QC Criteria

Mar 10, 2015

First Posted Date

Mar 11, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 10, 2015

Last Update Posted Date

Mar 11, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

In-Young Yoon, Professor, Seoul National University Bundang HospitalPrincipal Investigator

Lead Sponsor

Seoul National University Bundang HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention group	Experimental	Subjects who take modafinil for cancer-related fatigue for 4 weeks.	Drug: Modafinil

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Modafinil	Drug	200mg of modafinil daily for 4 weeks	Intervention group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hye youn Park, M.D.	Contact	+82-10-8010-0815		hypark@snubh.org

Overall Officials

Name	Affiliation	Role
Inyoung Yoon, M.D., Ph.D.	Department of Psychiatry, Seoul National University Bundang Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Bundang Hospital	Recruiting	Seongnam-si	Gyeonggi-do	ASI\|KR\|KS009\|SEONGNAM	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D005221	Fatigue

Ancestor Terms

ID	Term
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077408	Modafinil

Ancestor Terms

ID	Term
D001559	Benzhydryl Compounds
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic

Browse Leaves

Not provided

Browse Branches

Not provided