UMIN-CTR Clinical Trial

Basic information
Public title	Effect of head and neck cancer pretreatment training using expiratory muscle strength training (EMST)
Acronym	Effect of head and neck cancer pretreatment training using expiratory muscle strength training (EMST)
Scientific Title	Effect of head and neck cancer pretreatment training using expiratory muscle strength training (EMST)
Scientific Title:Acronym	Effect of head and neck cancer pretreatment training using expiratory muscle strength training (EMST)
Region	Japan

Condition
Condition	head and neck cancer
Classification by specialty	Oto-rhino-laryngology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Purpose of this study is efficacy of expiratory muscle strength training before (chemo)radiotherapy / Transoral Videolaryngoscopic Surgery(TOVS)
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	PEmax
Key secondary outcomes	Postoperative days for start meal,PAS(Penetration Aspiration Score),FOIS(functional oral intake scale)

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	EMST training
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Cancers of the supraglottis, oropharynx, or hypopharynx Treated by (C)RT or TOVS EMST training more than 2 weeks
Key exclusion criteria	EMST training less than 2 weeks
Target sample size	15

Research contact person
Name of lead principal investigator	1st name Shinichi Middle name Last name Taniai
Organization	National Defense Medical College
Division name	Department of Otolaryngology-Head and Neck Surgery
Zip code	359-8513
Address	3-2 Namiki, Tokorozawa Saitama
TEL	04-2995-1686
Email	taniai@ndmc.ac.jp

Public contact
Name of contact person	1st name Shinichi Middle name Last name Taniai
Organization	National Defense Medical College
Division name	Department of Otolaryngology-Head and Neck Surgery
Zip code	359-8513
Address	3-2 Namiki, Tokorozawa Saitama
TEL	04-2995-1686
Homepage URL
Email	taniai@ndmc.ac.jp

Sponsor
Institute	National Defense Medical College
Institute
Department

Funding Source
Organization	JST
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	National Defense Medical College
Address	3-2 Namiki, Tokorozawa Saitama
Tel	04-2995-1686
Email	taniai@ndmc.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 10 Month 30 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	Enrolling by invitation
Date of protocol fixation	2019 Year 03 Month 27 Day
Date of IRB	2019 Year 03 Month 27 Day
Anticipated trial start date	2019 Year 03 Month 27 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 10 Month 29 Day
Last modified on	2019 Year 10 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043771