UMIN-CTR Clinical Trial

Basic information
Public title	Examination of Factors Affecting Swallowing Function in Patients Following Resection for Head and Neck Tumor
Acronym	Swallowing Function in Patients Following Resection for Head and Neck Tumor
Scientific Title	Examination of Factors Affecting Swallowing Function in Patients Following Resection for Head and Neck Tumor
Scientific Title:Acronym	Swallowing Function in Patients Following Resection for Head and Neck Tumor
Region	Japan

Condition
Condition	Head and Neck Tumor
Classification by specialty	Oral surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To clarify the relationship between surgical resecti on and swallowing dysfunction by evaluating swal lowing function before and after surgery for patien ts scheduled to undergo head and neck tumor surg ery. To clarify the relationship between the videofluoro scopic swallowing study (VFSS) result and the sw allowing screening test result for patients who und erwent VFSS.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The score of swallowing screening tests
Key secondary outcomes	The score of penetration-aspiration(PA) scale

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Scheduled for surgical resection of head and neck tumor.
Key exclusion criteria	1) Having severe dementia or higher cerebral dysfunction with a preoperative revised Hasegawa's dementia scale under 20 points. 2) Discontinuing the study due to relocation or other reasons.
Target sample size	400

Research contact person
Name of lead principal investigator	1st name Hiromitsu Middle name Last name Kishimoto
Organization	Hyogo College of Medicine
Division name	Depertment of Dentistry and Oral & Maxillofacial Surgery
Zip code	663-8501
Address	1-1 Mukogawa-cho, Nishinomiya, Hyogo 663-8501 JAPAN
TEL	0798-45-6677
Email	kisihiro@hyo-med.ac.jp

Public contact
Name of contact person	1st name Yoko Middle name Last name Hasegawa
Organization	Hyogo College of Medicine
Division name	Depertment of Dentistry and Oral & Maxillofacial Surgery
Zip code	663-8501
Address	1-1 Mukogawa-cho, Nishinomiya, Hyogo 663-8501 JAPAN
TEL	0798-45-6677
Homepage URL
Email	cem17150@hyo-med.ac.jp

Sponsor
Institute	Hyogo College of Medicine
Institute
Department

Funding Source
Organization	Hyogo College of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Hyogo College of Medicine Institutional Review Board
Address	1-1 Mukogawa-cho, Nishinomiya, Hyogo 663-8501 JAPAN
Tel	0798456066
Email	rinri@hyo-med.ac.jp

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	2019 Year 03 Month 14 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	182
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	Completed
Date of protocol fixation	2014 Year 05 Month 01 Day
Date of IRB	2014 Year 06 Month 03 Day
Anticipated trial start date	2014 Year 06 Month 03 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	We observe the time-course changes of the dysphagia screening test results in head and neck tumor patients by evaluating the perioperative swallowing function.

Management information
Registered date	2019 Year 03 Month 13 Day
Last modified on	2022 Year 03 Month 16 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041182