Oral CancerNCT02048631
Analysis Of Sensory Recovery Of Donor Size And Quality Life In Oral Cancer Patients
An observational study of Oral Cancer, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
The aim of the study is to investigate post-surgery sensory impairment and life quality changes in oral cancer patients who underwent free flap (Free Flap) on post-operative 6 months, 12 months, and 24 months, respectively Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Oral Cancer
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- Jul 2013to Jun 2014
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Oral Cancer Patients Receiving Free Flap Reconstruction
Who may be able to join
- patients with American Society of Anesthesiologists physical status I-III
- Older than 20 patients
- Diagnosis of oral canaer ,requiring free flap reconstruction
Who cannot join
- Diagnosis of a serious mental illness involving formal thought disorder (e.g., schizophrenia) documented in medical record
- Cognitive with dementia, delirium
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807
About this study
Official title: Retrospective Analysis Of Sensory Recovery Of Donor Size And Related Quality Life In Oral Cancer Patients Receiving Free Flap Reconstruction
The aim of the study is to investigate post-surgery sensory impairment and life quality changes in oral cancer patients who underwent free flap (Free Flap) on post-operative 6 months, 12 months, and 24 months, respectively
- Conditions
- Oral Cancer
- Keywords
- oral cancer,Quality of life,Sensory
- Medical subject headings
- Mouth Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Oral Cancer Patients underwent Free Flap Reconstruction | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
sensory impairment on Donor site
comparison the contra-lateral side and donor site; measurement of thermal hyperalgesia with thermal roller temperatures measurement of allodynia with brush and cotton swab measurment of mechanical hyperalgesia with Von Frey filaments sensory impairments with roller wheel
Measured: up to 2 years
Secondary outcomes (1)
postoperative life quality using EORTC QLQ C-30 questionnaire .
Measured: postoperative 6 months to one year, postoperative 1 to 2 years, and over postoperative 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2014 (estimated)
- Study startJul 2013
- Primary completionFeb 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral CancerStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kao Pin Chang, MD,PhD., Study director, Department of Plastic Surgery,Kaohsiung Medical University,Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02048631
- Sponsor's protocol ID
- KMUH-IRB-20130085
- Status last verified
- Jul 2013
- First submitted
- 8 Oct 2013
- Last updated
- 7 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Analysis Of Sensory Recovery Of Donor Size And Related Quality Life In Oral Cancer Patients Receiving Free Flap Reconstruction
- ClinicalTrials.gov ID
- NCT02048631
- Acronym / sponsor ID
- KMUH-IRB-20130085
- Conditions
- Oral Cancer
- Keywords
- oral cancer,Quality of life,Sensory
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- Jul 2013 (actual)
- Primary completion
- Feb 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 29 Jan 2014 (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.
The aim of the study is to investigate post-surgery sensory impairment and life quality changes in oral cancer patients who underwent free flap (Free Flap) on post-operative 6 months, 12 months, and 24 months, respectively
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oral Cancer Patients underwent Free Flap Reconstruction | – | – |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Oral Cancer Patients Receiving Free Flap Reconstruction
Key inclusion criteria (3 listed)
- patients with American Society of Anesthesiologists physical status I-III
- Older than 20 patients
- Diagnosis of oral canaer ,requiring free flap reconstruction
Key exclusion criteria (2 listed)
- Diagnosis of a serious mental illness involving formal thought disorder (e.g., schizophrenia) documented in medical record
- Cognitive with dementia, delirium
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
sensory impairment on Donor site
Time frame: up to 2 years
comparison the contra-lateral side and donor site; measurement of thermal hyperalgesia with thermal roller temperatures measurement of allodynia with brush and cotton swab measurment of mechanical hyperalgesia with Von Frey filaments sensory impairments with roller wheel
1 secondary outcome
postoperative life quality using EORTC QLQ C-30 questionnaire .
Time frame: postoperative 6 months to one year, postoperative 1 to 2 years, and over postoperative 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2018.
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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.
Kao Pin Chang, MD,PhD. study director
Department of Plastic Surgery,Kaohsiung Medical University,Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Cancer, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 7 Mar 2018. 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 Taiwan. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sensory impairment on Donor site (time frame: up to 2 years). 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 7 Mar 2018.