UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058913 |
|---|---|
| Receipt number | R000067376 |
| Scientific Title | A Survey of Medical - Dental Collaboration for Management of Oral Mucositis Caused by Anticancer Drug Therapy |
| Date of disclosure of the study information | 2025/08/27 |
| Last modified on | 2025/08/27 18:21:45 |
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Basic information
Public title
A Survey of Medical - Dental Collaboration for Management of Oral Mucositis Caused by Anticancer Drug Therapy
Acronym
A Survey of Medical - Dental Collaboration for Management of Oral Mucositis Caused by Anticancer Drug Therapy
Scientific Title
A Survey of Medical - Dental Collaboration for Management of Oral Mucositis Caused by Anticancer Drug Therapy
Scientific Title:Acronym
A Survey of Medical - Dental Collaboration for Management of Oral Mucositis Caused by Anticancer Drug Therapy
Region
| Japan |
Condition
Condition
Oral mucositis caused by anticancer drug therapy
Classification by specialty
| Hematology and clinical oncology | Oral surgery | Dental medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
A web questionnaire survey will be conducted among Japanese physicians involved in cancer care, dentists, and oral surgeons to clarify the actual situation of oral mucositis management and medical-dental collaboration due to anticancer drug treatment.
Basic objectives2
Others
Basic objectives -Others
To identify current practices and challenges in the prevention and management of oral mucositis caused by anticancer drug therapy, as well as in medical-dental collaboration, across subgroups defined by medical specialty and experience with such collaboration.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
･Awareness of the importance of medical-dental collaboration
･Level of implementation and satisfaction with medical-dental collaboration
･Challenges in medical-dental collaboration
･Awareness of the importance of multidisciplinary collaboration
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Participants must meet all of the following eligibility criteria.
[Physicians involved in cancer care]
･At least 5 years of clinical experience (including residency)
･Working at a facility with more than 100 inpatient beds
･Primary specialty in one of the following:
-Gastrointestinal Surgery
-Gastrointestinal Medicine
-Thoracic Surgery
-Pulmonary Medicine
-Otorhinolaryngology
-Breast Surgery
-Obstetrics and Gynecology
-Urology
-Hematology
-Medical Oncology
･Has administered anticancer agents to at least 20 patients in the past 12 months
･Examined at least one patient per month for oral mucositis caused by anticancer therapy
･Able to provide electronic informed consent of their own free will
[Dentists / Oral Surgeons]
･At least 5 years of clinical experience (including residency)
･Primary specialty in Dentistry or Oral Surgery
･Has examined patients with oral mucositis caused by anticancer therapy
･Able to provide electronic informed consent of their own free will
Key exclusion criteria
No setting in this study
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Masaharu |
| Middle name | |
| Last name | Hanai |
Organization
Daiichi Sankyo Co., Ltd.
Division name
Oncology Medical Science Department II
Zip code
103-8426
Address
3-5-1 Nihonbashi Honcho, Chuo-ku, Tokyo, 103-8426, Japan
TEL
03-6225-1111
masaharu.hanai@daiichisankyo.com
Public contact
Name of contact person
| 1st name | Shimpei |
| Middle name | |
| Last name | Harita |
Organization
INTAGE Healthcare Inc.
Division name
Value & Access Department
Zip code
101-0062
Address
13F Ochanomizu SolaCity, 4-6 Kanda-Surugadai, Chiyoda-ku, Tokyo 101-0062, Japan
TEL
03-5294-8393
Homepage URL
Harita.48325@intage.com
Sponsor or person
Institute
Daiichi Sankyo Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Daiichi Sankyo Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Corporation TOUKEIKAI Kitamachi Clinic ERB
Address
1-1-3, Kichijoji-kitamachi, Musashino-shi, Tokyo,180-0001, Japan
Tel
03-6779-8116
chi-pr-ec-kitamachi@cmicgroup.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
| 2025 | Year | 08 | Month | 27 | 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 | 05 | Month | 30 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 18 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 16 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a web-based questionnaire survey targeting Japanese physicians involved in cancer care, dentists, and oral surgeons, aiming to investigate current practices of medical-dental collaboration in the management of oral mucositis caused by anticancer therapy.
Management information
Registered date
| 2025 | Year | 08 | Month | 27 | Day |
Last modified on
| 2025 | Year | 08 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067376
