UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057404 |
|---|---|
| Receipt number | R000065440 |
| Scientific Title | A Study on the Relationship Between Preoperative Oral Function, Physical Function, Nutritional Status, and Postoperative Outcomes in Elderly Cancer Patients. |
| Date of disclosure of the study information | 2025/04/01 |
| Last modified on | 2025/03/26 12:32:26 |
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Basic information
Public title
A Study on the Relationship Between Preoperative Oral Function, Physical Function, Nutritional Status, and Postoperative Outcomes in Elderly Cancer Patients.
Acronym
A Study on the Relationship Between Preoperative Oral Function, Physical Function, Nutritional Status, and Postoperative Outcomes in Elderly Cancer Patients.
Scientific Title
A Study on the Relationship Between Preoperative Oral Function, Physical Function, Nutritional Status, and Postoperative Outcomes in Elderly Cancer Patients.
Scientific Title:Acronym
Oral Function Study
Region
| Japan |
Condition
Condition
Malignant Tumors in the Respiratory, Gastric, Hepatobiliary, and Colorectal Areas.
Classification by specialty
| Dental medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the correlation between preoperative oral function, physical function, nutritional status, and postoperative outcomes.
Basic objectives2
Others
Basic objectives -Others
To clarify the status of preoperative oral function in elderly cancer patients.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The correlation between preoperative oral function and the incidence of postoperative complications of Grade 2 or higher.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
1 Cases screened by dental hygienists, nurses, dietitians, physical therapists, and speech-language pathologists.
2 Cases scheduled for resection surgery in the fields of gastric surgery, respiratory surgery, hepatobiliary surgery, and colorectal surgery.
3 Cases that received perioperative oral management in the dental and oral surgery department.
Key exclusion criteria
1 Cases with a history of treatment for head and neck cancer.
2 Cases where it was difficult to perform an accurate oral function test.
3 Cases where the planned surgery was canceled.
4 Cases that resulted in non-resective surgery (such as diagnostic laparoscopy, thoracoscopy only, bypass surgery only, etc.).
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | Megumi |
| Middle name | |
| Last name | Nagamine |
Organization
Shizuoka Cancer center
Division name
Division of Dentistry and Oral surgery
Zip code
411-8777
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan
TEL
055-989-5222
m.nagamine@scchr.jp
Public contact
Name of contact person
| 1st name | Megumi |
| Middle name | |
| Last name | Nagamine |
Organization
Shizuoka Cancer Center
Division name
Division of Dentistry and Oral Surgery
Zip code
411-8777
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan
TEL
055-989-5222
Homepage URL
m.nagamine@scchr.jp
Sponsor or person
Institute
Shizuoka cancer center
Institute
Department
Personal name
Funding Source
Organization
Shizuoka cancer center
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
Shizuoka Cancer Center Institutional Review Board
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan
Tel
055-989-5222
irb@scchr.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 | 04 | 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
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
Suspended
Date of protocol fixation
| 2025 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 05 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | 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
Retrospective observational study
Management information
Registered date
| 2025 | Year | 03 | Month | 26 | Day |
Last modified on
| 2025 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065440
