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Trial record 40 of 239 for:    (armodafinil)

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

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ClinicalTrials.gov Identifier: NCT02385656
Recruitment Status : Unknown
Verified March 2015 by In-Young Yoon, Seoul National University Bundang Hospital.
Recruitment status was:  Recruiting
First Posted : March 11, 2015
Last Update Posted : March 11, 2015
Sponsor:
Information provided by (Responsible Party):
In-Young Yoon, Seoul National University Bundang Hospital

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

Condition or disease Intervention/treatment Phase
Fatigue Drug: Modafinil Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Efficacy and Tolerability of Modafinil for Fatigue and Daytime Sleepiness in Cancer Patients: Preliminary Study
Study Start Date : March 2013
Estimated Primary Completion Date : February 2016
Estimated Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue

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 Name: Provigil




Primary Outcome Measures :
  1. severity of fatigue (Brief Fatigue Inventory) [ Time Frame: 4 weeks ]
    Brief Fatigue Inventory



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02385656


Contacts
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Contact: Hye youn Park, M.D. +82-10-8010-0815 hypark@snubh.org

Locations
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Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seongnam-si, Gyeonggi-do, Korea, Republic of, ASI|KR|KS009|SEONGNAM
Contact: Hye youn Park, M.D.    +82-10-8010-0815    hypark@snubh.org   
Sponsors and Collaborators
Seoul National University Bundang Hospital
Investigators
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Principal Investigator: Inyoung Yoon, M.D., Ph.D. Department of Psychiatry, Seoul National University Bundang Hospital

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Responsible Party: In-Young Yoon, Professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT02385656     History of Changes
Other Study ID Numbers: B-1302/191-003
First Posted: March 11, 2015    Key Record Dates
Last Update Posted: March 11, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
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Fatigue
Sleepiness
Signs and Symptoms
Modafinil
Central Nervous System Stimulants
Physiological Effects of Drugs
Wakefulness-Promoting Agents
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action