UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043246 |
|---|---|
| Receipt number | R000049266 |
| Scientific Title | Study of oral function and temporal muscle atrophy for elder people after craniotomy. |
| Date of disclosure of the study information | 2021/03/01 |
| Last modified on | 2023/11/25 12:54:05 |
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Basic information
Public title
Study of oral function and temporal muscle atrophy for elder people after craniotomy.
Acronym
Study of oral function and temporal muscle atrophy for elder people after craniotomy.
Scientific Title
Study of oral function and temporal muscle atrophy for elder people after craniotomy.
Scientific Title:Acronym
Study of oral function and temporal muscle atrophy for elder people after craniotomy.
Region
| Japan |
Condition
Condition
Brain tumor
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate temporal muscle atrophy and oral function after craniotomy in the elderly.
Evaluate whether occlusal force training can prevent postoperative temporal muscle atrophy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bite force
Temporal muscle atrophy in MRI
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Bite force training with gum
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Those who are 65 years old or older at the time of obtaining consent
Those who need craniotomy with temporalis muscle dissection for brain tumor
Those who have a period of 2 weeks or more before surgery
Key exclusion criteria
Cases in which treatment intervention is required as soon as possible and bite force training for 2 weeks cannot be performed
Cases in which occlusal force training cannot be performed, such as being unable to chew gum
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Osamu |
| Middle name | |
| Last name | Akiyama |
Organization
Juntendo University Faculty of Medicine
Division name
Department of Neurosurgery
Zip code
113-0033
Address
2-1-1 Hongo Bunkyo-ku Tokyo Japan
TEL
03-3813-3111
akiyamao@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Osamu |
| Middle name | |
| Last name | Akiyama |
Organization
Juntendo University Faculty of Medicine
Division name
Department of Neurosurgery
Zip code
113-0033
Address
2-1-1 Hongo Bunkyo-ku Tokyo Japan
TEL
03-3813-3111
Homepage URL
akiyamao@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo University Hospital
Address
2-1-1 Hongo Bunkyo-ku Tokyo Japan
Tel
03-3813-3111
akiyamao@juntendo.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
| 2021 | Year | 03 | Month | 01 | 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
| Delay expected |
Results Delay Reason
Because of COVID-19
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
| 2021 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2024 | 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
| 2021 | Year | 02 | Month | 04 | Day |
Last modified on
| 2023 | Year | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049266
