UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061724 |
|---|---|
| Receipt number | R000069966 |
| Scientific Title | Association between oral function and physical function in patients with esophageal cancer: Combined assessment of cancer locomotive syndrome and oral function training using chewing gum |
| Date of disclosure of the study information | 2026/06/01 |
| Last modified on | 2026/05/27 18:20:42 |
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Basic information
Public title
Association between oral function and physical function in patients with esophageal cancer: Combined assessment of cancer locomotive syndrome and oral function training using chewing gum
Acronym
Association between oral function and physical function in patients with esophageal cancer: Combined assessment of cancer locomotive syndrome and oral function training using chewing gum
Scientific Title
Association between oral function and physical function in patients with esophageal cancer: Combined assessment of cancer locomotive syndrome and oral function training using chewing gum
Scientific Title:Acronym
Association between oral function and physical function in patients with esophageal cancer: Combined assessment of cancer locomotive syndrome and oral function training using chewing gum
Region
| Japan |
Condition
Condition
Esophageal cancer
Classification by specialty
| Gastrointestinal surgery | Oral surgery | Rehabilitation medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
At our hospital, we continuously evaluate "Cancer Locomotive Syndrome" (Cancer Loco) to maintain and improve ADL, QOL, physical function, oral function, and nutritional status in cancer patients. Specifically, we have observed that patients undergoing surgical treatment for esophageal cancer often require an extended period to recover their occlusal force due to postoperative dietary restrictions. This study aims to introduce "masticatory training using chewing gum" to promote chewing movements and to verify its therapeutic effect on occlusal force in these patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Occlusal force measured using an impulse-type occlusal force meter (Oramo-bf). The assessment will be conducted at two time points: preoperatively and one month postoperatively. Two measurements will be taken at each session, and the maximum value will be used for analysis.
Key secondary outcomes
1. Activities of Daily Living (ADL): Functional Independence Measure (FIM) score.
2. Physical Activity: Measured using a triaxial accelerometer (OMRON HJA-750C).
3. Physical Function: Grip strength, Short Physical Performance Battery (SPPB), gait analysis (AYUMiEYE), and Locomotive Syndrome Risk Test (Loco-check).
4. Oral Function: Masticatory performance (using masticatory check gum), Oral Frailty 5-item Checklist (OF-5), tongue pressure, oral diadochokinesis (ODK), and Oral Health Assessment Tool (OHAT-J).
5. Psychological and Fatigue Status: Hospital Anxiety and Depression Scale (HADS) and Functional Assessment of Cancer Therapy-General (FACT-G) scores.
6. Nutritional Status: Body fluid volume measurement, Malnutrition Universal Screening Tool (MUST), and Global Leadership Initiative on Malnutrition (GLIM) criteria.
Timing of assessment: Preoperatively and one month postoperatively.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Maneuver | Other |
Interventions/Control_1
Selection and Procedures:
Participants are selected during their first visit to the Cancer Locomotive Syndrome Outpatient Clinic. The study follows a pre-defined observation and examination schedule. As part of standard clinical care for cancer locomotive management, no changes to the treatment plan will be made except for the addition of gum training.
Intervention Details:
Timing of Initiation: After discharge from the ICU.
Duration: From the initiation of training until one month postoperatively (approximately 30 days).
Frequency and Dose: Chewing two pieces of gum for 5 minutes per session, twice daily.
Method: This masticatory training is performed daily for 30 consecutive days. The training is integrated into the standard perioperative rehabilitation program without altering other medical interventions.
Interventions/Control_2
This group includes past cases who received standard "Cancer Locomotive Management" and routine perioperative care (early mobilization, respiratory physiotherapy, and swallowing therapy) before the introduction of the gum training. While these patients underwent standard cancer locomotive assessments and interventions, they did not perform the specific masticatory training using chewing gum (5 minutes per session, twice daily, for 30 days) defined in this study.
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Inclusion Criteria:
Patients aged 20 years or older.
Patients with esophageal cancer scheduled for surgical treatment.
Patients enrolled in the study "Physical function and QOL improvement through multidisciplinary intervention for locomotive syndrome in cancer patients" (Approval No. 2025-050).
Patients evaluated by a dentist as capable of performing masticatory training using gum.
Patients capable of preoperative and postoperative follow-up assessments.
Patients who have provided written informed consent for participation in this study.
Key exclusion criteria
Participants meeting any of the following criteria will be excluded:
Patients with significant cognitive decline, persistent delirium, or psychiatric disorders that make it difficult to understand study procedures or complete assessments.
Patients for whom the continuation of gum training or rehabilitation therapy is difficult due to severe postoperative complications or comorbidities.
Patients with dental conditions (e.g., severe tooth loss or significant oral pain) that prevent safe gum chewing.
Patients otherwise judged as inappropriate for participation by the principal investigator.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kazuma |
| Middle name | |
| Last name | Mastunaga |
Organization
Kagawa University Hospital
Division name
Division of Rehabilitation, Department of Medical Technology
Zip code
761-0793
Address
1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa
TEL
087-891-2306
matsunaga.kazuma@kagawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuma |
| Middle name | |
| Last name | Matsunaga |
Organization
Kagawa University Hospital
Division name
Division of Rehabilitation, Department of Medical Technology
Zip code
761-0793
Address
1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa
TEL
087-891-2306
Homepage URL
matsunaga.kazuma@kagawa-u.ac.jp
Sponsor or person
Institute
Kagawa University Hospital
Institute
Department
Personal name
Kazuma matsunaga
Funding Source
Organization
Not Applicable
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kagawa University Hospital
Address
1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa
Tel
087-891-2306
matsunaga.kazuma@kagawa-u.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
香川県
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 05 | Month | 27 | Day |
Date of IRB
| 2026 | Year | 05 | Month | 27 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2030 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 05 | Month | 28 | Day |
Last modified on
| 2026 | Year | 05 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069966
