UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038427
Receipt number R000043771
Scientific Title Effect of head and neck cancer pretreatment training using expiratory muscle strength training (EMST)
Date of disclosure of the study information 2019/10/30
Last modified on 2019/10/29 15:27:24

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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 or person

Institute

National Defense Medical College

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043771


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name