FatiguePhase 4NCT02385656
The Efficacy and Tolerability of Modafinil for Fatigue and Daytime Sleepiness in Cancer Patients: Preliminary Study
A Phase 4 study testing Modafinil in people with Fatigue, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
Open-pilot study for the efficacy and tolerability of modafinil on the fatigue and somnolence in cancer-patients. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Fatigue
- What is being tested?
- Modafinil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2013to Feb 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- solid cancer patient
- age of 20-65 years old
- subjects who scored =4 or >4 on the Brief Fatigue Inventory
- subjects with informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, ASI|KR|KS009|SEONGNAM
Hye youn Park, M.D., +82-10-8010-0815, hypark@snubh.org
About this study
Open-pilot study for the efficacy and tolerability of modafinil on the fatigue and somnolence in cancer-patients.
Read the 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.
- Conditions
- Fatigue
- Being tested
- Modafinil
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ModafinilDrug
Also called Provigil
200mg of modafinil daily for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Subjects who take modafinil for cancer-related fatigue for 4 weeks. Receives: Drug: Modafinil |
What is being measured
The primary outcome is the main question the study is designed to answer.
severity of fatigue (Brief Fatigue Inventory)
Brief Fatigue Inventory
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2015 (estimated)
- Study startMar 2013
- Primary completionFeb 2016 (estimated)
- Study completionFeb 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FatigueStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, In-Young Yoon, Seoul National University Bundang Hospital
- Investigators
- Inyoung Yoon, M.D., Ph.D., Principal investigator, Department of Psychiatry, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02385656
- Sponsor's protocol ID
- B-1302/191-003
- Status last verified
- Mar 2015
- First submitted
- 2 Mar 2015
- Last updated
- 11 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Tolerability of Modafinil for Fatigue and Daytime Sleepiness in Cancer Patients: Preliminary Study
- ClinicalTrials.gov ID
- NCT02385656
- Acronym / sponsor ID
- B-1302/191-003
- Conditions
- Fatigue
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Feb 2016 (estimated)
- Study completion
- Feb 2016 (estimated)
- First posted
- 11 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Drug: ModafinilSubjects who take modafinil for cancer-related fatigue for 4 weeks. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- solid cancer patient
- age of 20-65 years old
- subjects who scored =4 or >4 on the Brief Fatigue Inventory
- subjects with informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ModafinilAlso: Provigil200mg of modafinil daily for 4 weeks | Drug | Intervention group |
Primary outcome
severity of fatigue (Brief Fatigue Inventory)
Time frame: 4 weeks
Brief Fatigue Inventory
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Inyoung Yoon, M.D., Ph.D. principal investigator
Department of Psychiatry, Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Modafinil in people with Fatigue, run by Seoul National University Bundang Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hye youn Park, M.D. (+82-10-8010-0815, hypark@snubh.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
severity of fatigue (Brief Fatigue Inventory) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2015.