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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000022881
Receipt No. 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

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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
Email 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
Email bymyself@med.niigata-u.ac.jp

Sponsor
Institute niigata university graduate school of medical and dental sciences
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026292

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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