NCT02385656

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2013

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

March 2, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 11, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

March 11, 2015

Status Verified

March 1, 2015

Enrollment Period

2.9 years

First QC Date

March 2, 2015

Last Update Submit

March 10, 2015

Conditions

Fatigue

Outcome Measures

Primary Outcomes (1)

  • severity of fatigue (Brief Fatigue Inventory)

    Brief Fatigue Inventory

    4 weeks

Study Arms (1)

Intervention group

EXPERIMENTAL

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

Drug: Modafinil

Interventions

ModafinilDRUG

200mg of modafinil daily for 4 weeks

Also known as: Provigil
Intervention group

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • solid cancer patient
  • age of 20-65 years old
  • subjects who scored =4 or \>4 on the Brief Fatigue Inventory
  • subjects with informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, ASI|KR|KS009|SEONGNAM, South Korea

RECRUITING

MeSH Terms

Conditions

Fatigue

Interventions

Modafinil

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzhydryl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Inyoung Yoon, M.D., Ph.D.

    Department of Psychiatry, Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hye youn Park, M.D.

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 2, 2015

First Posted

March 11, 2015

Study Start

March 1, 2013

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

March 11, 2015

Record last verified: 2015-03

Locations

KR(1)