UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057795 |
|---|---|
| Receipt number | R000065994 |
| Scientific Title | Single-blind randomized controlled trial of the effect of preoperative expiratory muscle training on postoperative swallowing function in patients with esophageal cancer: A phase II trial |
| Date of disclosure of the study information | 2025/06/30 |
| Last modified on | 2025/05/02 05:22:33 |
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Basic information
Public title
Single-blind randomized controlled trial of the effect of preoperative expiratory muscle training on swallowing function in patients with esophageal cancer: A phase II trial
Acronym
Preoperative expiratory muscle training and swallowing function in esophageal cancer patients
Scientific Title
Single-blind randomized controlled trial of the effect of preoperative expiratory muscle training on postoperative swallowing function in patients with esophageal cancer: A phase II trial
Scientific Title:Acronym
Preoperative expiratory muscle training and postoperative swallowing function in esophageal cancer patients
Region
| Japan |
Condition
Condition
Patients with thoracic esophageal cancer
Classification by specialty
| Gastrointestinal surgery | Rehabilitation medicine | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This phase II single-blind randomized controlled trial aims to evaluate the efficacy of expiratory muscle training during neoadjuvant therapy on postoperative swallowing function in patients with thoracic esophageal cancer undergoing esophagectomy.
Basic objectives2
Others
Basic objectives -Others
Postoperative incidence of aspiration will be compared between the two groups to determine the effect size, which will inform the design of a future multicenter collaborative trial.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Penetration-Aspiration Scale (PAS) score assessed during video-fluoroscopic swallowing study
Key secondary outcomes
Repeated Saliva Swallowing Test, Functional Oral Intake Scale, Tongue pressure
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
Sham-Expiratory muscle training
Interventions/Control_2
Expiratory muscle 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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Eligible participants must meet all of the following criteria and provide written informed consent:
Patients aged 40 years or older with esophageal cancer scheduled to undergo esophagectomy and reconstruction following neoadjuvant therapy at Kindai University Hospital.
Patients receiving initial treatment for esophageal cancer.
Patients without severe comorbidities involving major organs (e.g., bone marrow, heart, liver, kidneys).
Patients who have received a full explanation of the study and have provided written informed consent.
Patients who are able to walk independently.
Key exclusion criteria
Participants meeting any of the following criteria will be excluded from the study:
Patients scheduled to undergo staged esophageal reconstruction or total laryngectomy.
Patients with contraindications to the use of the expiratory muscle training device (EX-1 Medic), including:
Patients with asthma who frequently experience exacerbations
Patients with tympanic membrane perforation or other ear injuries
Patients with markedly elevated left ventricular end-diastolic volume or pressure
Patients who have experienced worsening signs or symptoms of heart failure following respiratory muscle training, or those diagnosed by a physician as being at high risk of such deterioration
Patients with a history of costochondritis or those diagnosed as likely to have it
Patients with active infections or other severe complications* who are judged by the attending physician to be at risk of adverse events associated with expiratory muscle training (EMT), such as increased dyspnea due to respiratory muscle fatigue, decreased consciousness due to hyperventilation, or syncope due to abrupt changes in blood pressure or hemodynamics caused by intrathoracic pressure fluctuations.
Patients with disorientation or psychiatric disorders that would preclude appropriate participation in the study.
Patients deemed by the investigator or sub-investigator to be unsuitable for EMT due to a high risk of pneumothorax from extensive emphysematous lesions or giant bullae, leading to increased physical burden or potential harm from participation in the study.
*Severe complications include severe pneumonia, cardiac disease, hepatic disease, renal disease; patients with cardiac events (e.g., unstable angina, myocardial infarction, percutaneous coronary intervention, coronary artery bypass surgery) within the past month; cerebrovascular disease within the past 6 months; or the presence of extensive emphysematous changes or giant bullae.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Higashimoto |
Organization
Faculty of Medicine, Kindai university
Division name
Department of Rehabilitation Medicine
Zip code
589-5811
Address
377-2, Ohno-Higashi Osakasayama-City, JAPAN
TEL
072-366-0221
yhigashi@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Mizusawa |
Organization
Kindai university hospital
Division name
Department of rehabilitation medicine
Zip code
589-5811
Address
377-2, Ohno-Higashi Osakasayama-City, JAPAN
TEL
072-366-0221
Homepage URL
hiroki-mizusawa@med.kindai.ac.jp
Sponsor or person
Institute
Kindai university hospital
Institute
Department
Personal name
Funding Source
Organization
Grant-In-Aid for Scientific Research from the Ministry of Education, Science and Culture of the Japanese Government
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
he Committee for Ethics of the Kindai University School of Medicine
Address
377-2, Ohno-Higashi Osakasayama-City, JAPAN
Tel
072-366-0221
zizen@med.kindai.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
| 2025 | Year | 06 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 09 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 25 | Day |
Last follow-up date
| 2029 | Year | 05 | 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
| 2025 | Year | 05 | Month | 08 | Day |
Last modified on
| 2025 | Year | 05 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065994
