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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT02243722 |
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Date of registration:
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16/09/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Establish Quantitative Measurements of Laryngeal Sensorimotor Functions and Evaluating the Grade of Phonation and Swallowing Impairment
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Scientific title:
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Establish Comprehensive Quantitative Measurements of Laryngeal Sensorimotor Functions and Evaluating the Grade of Phonation and Swallowing Impairment |
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Date of first enrolment:
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July 2014 |
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Target sample size:
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70 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT02243722 |
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Study type:
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Observational [Patient Registry] |
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Study design:
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Observational Model: Cohort, Time Perspective: Cross-Sectional
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Phase:
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N/A
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Countries of recruitment
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Taiwan
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Contacts
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Name:
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Tuan-Jen Fang, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Chang Gung Memorial Hospital |
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Name:
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Tuan-Jen Fang, MD |
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Address:
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Telephone:
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Email:
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fang3109@cgmh.org.tw |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients with laryngopharyngeal or esophageal cancer who have taken active therapy
and are not neck tissue damage.
- Patients with clear conscious and stable mental status
Exclusion Criteria:
- Patients who cannot sit for longer than 30 minutes or received other vocal cord
treatments before the selection
- Pregnant and breastfeeding women
- Patients with communication disorder
Age minimum:
20 Years
Age maximum:
85 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Unilateral Vocal Cord Paralysis
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Primary Outcome(s)
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Laryngo-pharyngeal mucosa sensation test
[Time Frame: Baseline:Within 3-6 months after synptom occurs]
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Fiberoptic endoscopic evaluation of swallowing (FEES)
[Time Frame: Baseline:Within 3-6 months after synptom occurs]
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Secondary Outcome(s)
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Disease related life quality assessment: FACT-H&N, FACT-E
[Time Frame: Baseline:Within 3-6 months after synptom occurs]
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laboratory voice analysis
[Time Frame: Baseline:Within 3-6 months after synptom occurs]
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laryngeal electromyography
[Time Frame: Baseline:Within 3-6 months after synptom occurs]
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Voice Handicap Index (VHI)
[Time Frame: Baseline:Within 3-6 months after synptom occurs]
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voice range profile
[Time Frame: Baseline:Within 3-6 months after synptom occurs]
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Secondary ID(s)
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102-5333A3
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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