UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059772 |
|---|---|
| Receipt number | R000068348 |
| Scientific Title | Exploratory Study on Postoperative Tongue Electrical Stimulation for Esophageal Cancer |
| Date of disclosure of the study information | 2025/11/13 |
| Last modified on | 2025/11/13 22:31:39 |
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Basic information
Public title
Exploratory Study on Postoperative Tongue Electrical Stimulation for Esophageal Cancer
Acronym
Exploratory Study on Postoperative Tongue Electrical Stimulation for Esophageal Cancer
Scientific Title
Exploratory Study on Postoperative Tongue Electrical Stimulation for Esophageal Cancer
Scientific Title:Acronym
Exploratory Study on Postoperative Tongue Electrical Stimulation for Esophageal Cancer
Region
| Japan |
Condition
Condition
Esophageal cancer
Classification by specialty
| Gastrointestinal surgery | Rehabilitation medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate the effects of electrical stimulation of the tongue from the day after surgery until oral intake is initiated in patients with esophageal cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Change rate in tongue pressure before and after treatment
Key secondary outcomes
Implementation rate of electrical stimulation therapy
Change in saliva volume before and after treatment
Change in repeated saliva swallowing test
Change rate in bite force
Adverse events associated with electrical stimulation therapy
Adverse events associated with surgery
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
| Other |
Interventions/Control_1
Tongue electrical stimulation therapy
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
Patients diagnosed with pathologic esophageal cancer
Patients scheduled to undergo subtotal esophagectomy
Patients who have been fully informed about their participation in this study, and who have given their free and voluntary consent based on their full understanding of the study
Key exclusion criteria
Patients who underwent combined pharyngolaryngeal resection
Patients with a history of head and neck cancer treatment
Patients with communication difficulties, such as those unable to understand the purpose of the study
Patients deemed unsuitable as research subjects by the principal investigator
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Yamasaki |
Organization
Kasai Medical University
Division name
Department of Upper Gastrointestinal Surgery
Zip code
573-1010
Address
2-5-1,Shinmachi, Hirakata, Osaka 573-1010, JAPAN
TEL
072-804-010
yamasaki.mak@kmu.ac.jp
Public contact
Name of contact person
| 1st name | Takuya |
| Middle name | |
| Last name | Fukushima |
Organization
Kasai Medical University
Division name
Faculty of Rehabilitation
Zip code
573-1136
Address
18-89, Uyamahigashicho, Hirakata, Osaka, 573-1136, JAPAN
TEL
072-856-2115
Homepage URL
fukushima.tky@kmu.ac.jp
Sponsor or person
Institute
Kasai Medical University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology - JAPAN
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
Kasai Medical University
Address
2-5-1,Shinmachi, Hirakata, Osaka 573-1010, JAPAN
Tel
072-804-0101
fukushima.tky@kmu.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 | 11 | Month | 13 | 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 | 08 | Month | 20 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 26 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 17 | Day |
Last follow-up date
| 2027 | 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
| 2025 | Year | 11 | Month | 13 | Day |
Last modified on
| 2025 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068348
