UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042927 |
|---|---|
| Receipt number | R000049002 |
| Scientific Title | The effect of telemedicine intevention on oral function in head and neck tumor patients |
| Date of disclosure of the study information | 2021/12/31 |
| Last modified on | 2023/03/12 16:11:06 |
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Basic information
Public title
The effect of telemedicine intevention on oral function in head and neck tumor patients
Acronym
ETIOFHNTP
Scientific Title
The effect of telemedicine intevention on oral function in head and neck tumor patients
Scientific Title:Acronym
ETIOFHNTP
Region
| Asia(except Japan) |
Condition
Condition
Finished
Classification by specialty
| Oral surgery | Rehabilitation medicine | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The effect of telemedicine intevention on oral function in head and neck tumor patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
At the beginning of training (T0) and 1 month (T1), 3 months (T2) and 6 months (T3) after training, patients' masticatory ability (mastication efficiency, maximum bite force and mouth opening) and swallowing ability (water swallowing test) was measured. Modified Sato questionnaire and MD Anderson dysphagia inventory (MDADI) were used for self-evaluation of chewing and swallowing ability.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Oral rehabilitation training guidance by telemedicine intevention
Interventions/Control_2
Self-tratining
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients with primary oral and maxillofacial tumor receiving surgical treatment; 2. Agree with the content of this clinical study and be able to return visit regularly after operation; 3. Be able to carry out corresponding rehabilitation training independently; 4. Patients without other central nervous system diseases or other diseases affecting oral function.
Key exclusion criteria
1. Recurrence of oral and maxillofacial tumor, or distant lymph node metastasis confirmed by pathology; 2. Patients with oral trauma history or temporomandibular joint disorders that may affect chewing and swallowing function; 3. Patients with serious systemic diseases, unable to cooperate with oral function detection or unable to carry out self-training; 4. Patients who were not competent to oral feeding postoperatively including patients with long-term nasogastric feeding tube.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Changfu |
| Middle name | |
| Last name | Sun |
Organization
Stomatology hospital of China Medical University
Division name
Department of oral and maxillofacial surgery
Zip code
110002
Address
No. 117, Nanjing North Street, Heping District
TEL
+86-24-31927872
changfusun@hotmail.com
Public contact
Name of contact person
| 1st name | Pai |
| Middle name | |
| Last name | Pang |
Organization
Stomatology hospital of China Medical University
Division name
Department of oral and maxillofacial surgery
Zip code
110002
Address
No. 117, Nanjing North Street, Heping District
TEL
+86-24-31927739
Homepage URL
pangpai@163.com
Sponsor or person
Institute
Stomatology hospital of China Medical University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Stomatology hospital of China Medical University
Address
No. 117, Nanjing North Street, Heping District
Tel
+86-24-13700022978
413959283@qq.com
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 | 12 | Month | 31 | Day |
Related information
URL releasing protocol
None
Publication of results
Unpublished
Result
URL related to results and publications
None
Number of participants that the trial has enrolled
64
Results
A total of 64 participants were included. The masticatory efficiency scores of the TMI group were significantly better than those of the control group at T2 and T3, and maximum mouth opening was better at T2 and T3. In water swallowing test, the TMI group had better scores at T2 and T3. The scores of MDADI scale in TMI group were better than those in the control group after 3 months of training.
Results date posted
| 2021 | Year | 01 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Among the patients who received masticatory rehabilitation training, 5 patients with benign tumors were included, including 3 cases of ameloblastoma (2 cases in TMI group and 1 case in control group), 1 case of oral lichen planus (TMI group) and 1 case of myofibroblastoma (control group). Among the malignant tumor patients included, 1 verrucous carcinoma was included in TMI group, and the other patients were diagnosed as SCC. The patients receiving swallowing rehabilitation training were all malignant, including 1 case of pleomorphic adenocarcinoma (TMI group), 1 case of myoepithelial carcinoma (control group) and 1 case of adenoid cystic carcinoma (TMI group), and the rest patients were SCC. No patients underwent secondary operation during peri-operative stage and the period of postoperative rehabilitation training.
Participant flow
Nine patients were lost to follow-up, 1 patient dropped out of the project, and 1 patient passed away before the end of the study. Finally, 26 patients received masticatory function rehabilitation training and evaluation (TMI group 13 cases, control group 13 cases), 38 patients received swallowing function rehabilitation training and evaluation (TMI group 20 cases, control group 18 cases).
Adverse events
None
Outcome measures
Patients' masticatory ability (mastication efficiency, maximum bite force and mouth opening) and swallowing ability (water swallowing test) was measured. Modified Sato questionnaire and MD Anderson dysphagia inventory (MDADI) were used for self-evaluation of chewing and swallowing ability.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2018 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 07 | Month | 01 | 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 | 01 | Month | 06 | Day |
Last modified on
| 2023 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049002
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