UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022881 |
|---|---|
| Receipt number | R000026292 |
| Scientific Title | Examination in the protective efficacy hypopharyngeal cancer chemoradiation treatment of radiation therapy induced respiratory complications with deglutition rehabilitation |
| Date of disclosure of the study information | 2016/07/01 |
| Last modified on | 2017/06/30 16:56:30 |
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Basic information
Public title
Examination in the protective efficacy hypopharyngeal cancer chemoradiation treatment of radiation therapy induced respiratory complications with deglutition rehabilitation
Acronym
Examination in the protective efficacy hypopharyngeal cancer chemoradiation treatment of radiation therapy induced respiratory complications with deglutition rehabilitation
Scientific Title
Examination in the protective efficacy hypopharyngeal cancer chemoradiation treatment of radiation therapy induced respiratory complications with deglutition rehabilitation
Scientific Title:Acronym
Examination in the protective efficacy hypopharyngeal cancer chemoradiation treatment of radiation therapy induced respiratory complications with deglutition rehabilitation
Region
| Japan |
Condition
Condition
hypopharyngeal cancer
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Early deglutition rehabilitation for the hypopharyngeal cancer examines having effect on deglutition function or not.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
I evaluate the deglutition function treatment three months later and six months later
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
I give deglutition rehabilitation by the indirect training and perform it before every meal for 30 minutes.
Interventions/Control_2
I do not give deglutition rehabilitation by the indirect training
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
the case that can ingest it and does not have an obstacle for a deglutition function
performance status 0
Key exclusion criteria
the case that it is poor in ingestion, and has an obstacle for a deglutition function
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | keisuke yamazaki |
Organization
niigata university graduate school of medical and dental sciences
Division name
department of otolaryngology head and neck surgery
Zip code
Address
1 757 asahimachidori chuoku niigata city niigata 9518510 japan
TEL
+81-25-227-2306
bymyself@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | keisuke yamazaki |
Organization
niigata university graduate school of medical and dental sciences
Division name
department of otolaryngology head and neck surgery
Zip code
Address
1 757 asahimachidori chuoku niigata city niigata 9518510 japan
TEL
+81-25-227-2306
Homepage URL
bymyself@med.niigata-u.ac.jp
Sponsor or person
Institute
niigata university graduate school of medical and dental sciences
Institute
Department
Personal name
Funding Source
Organization
niigata university graduate school of medical and dental sciences
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2016 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | Month | 22 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 06 | Month | 24 | Day |
Last modified on
| 2017 | Year | 06 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026292
