UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059464 |
|---|---|
| Receipt number | R000068012 |
| Scientific Title | A single-arm phase II study evaluating the preventive effect of dental intervention on oral mucositis during the initiation of datopotamab deruxtecan in patients with advanced breast cancer |
| Date of disclosure of the study information | 2025/10/23 |
| Last modified on | 2025/10/20 11:15:34 |
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Basic information
Public title
A single-arm phase II study evaluating the preventive effect of dental intervention on oral mucositis during the initiation of datopotamab deruxtecan in patients with advanced breast cancer
Acronym
A single-arm phase II study evaluating the preventive effect of dental intervention on oral mucositis during the initiation of datopotamab deruxtecan in patients with advanced breast cancer
Scientific Title
A single-arm phase II study evaluating the preventive effect of dental intervention on oral mucositis during the initiation of datopotamab deruxtecan in patients with advanced breast cancer
Scientific Title:Acronym
A single-arm phase II study evaluating the preventive effect of dental intervention on oral mucositis during the initiation of datopotamab deruxtecan in patients with advanced breast cancer
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Breast surgery | Oral surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether dental intervention can prevent the occurrence of oral mucositis induced by datopotamab deruxtecan(Dato-DXd).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
The incidence of all-grade oral mucositis (evaluated according to the Common Terminology Criteria for Adverse Events [CTCAE] version 5.0) up to the day of the fifth course of Dato-DXd administration.
Key secondary outcomes
Incidence of grade 3 or higher oral mucositis up to the day of the fifth course of Dato-DXd administration (evaluated according to CTCAE version 5.0).
Changes in oral conditions up to the day of the fifth course of Dato-DXd administration (evaluated according to the Revised Oral Assessment Guide).
Changes in quality of life up to the day of the fifth course of Dato-DXd administration (assessed using the EORTC QLQ-C30 questionnaire, version 3.0).
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom | Maneuver |
Interventions/Control_1
The following dental interventions will be performed: evaluation of the oral environment, dental calculus removal, professional mechanical tooth cleaning (PMTC), toothbrushing instruction, tongue coating removal instruction, and gargling instruction.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with breast cancer eligible for Dato-DXd under Japanese insurance coverage and scheduled to receive Dato-DXd treatment.
Key exclusion criteria
1. Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 3 or higher at the time of consent.
2. Patients who have oral mucositis at the time of consent.
3. Patients who are scheduled to undergo dental procedures involving polishing, puncture, incision, or local anesthesia at the time of consent.
4. Patients who wish to receive dental care at another institution.
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Akihiko |
| Middle name | |
| Last name | Shimomura |
Organization
Japan Institute for Health Security
Division name
Department of Breast and Medical Oncology, National Center for Global Health and Medicine
Zip code
162-8655
Address
1-21-1 Toyama-cho, Shinjuku-ku, Tokyo, Japan
TEL
0332027181
shimomura.a@jihs.go.jp
Public contact
Name of contact person
| 1st name | Kenju |
| Middle name | |
| Last name | Ando |
Organization
Japan Institute for Health Security
Division name
Department of Breast and Medical Oncology, National Center for Global Health and Medicine
Zip code
1628655
Address
1-21-1 Toyama-cho, Shinjuku-ku, Tokyo, Japan
TEL
0332027181
Homepage URL
ando.k@jihs.go.jp
Sponsor or person
Institute
Japan Institute for Health Security
Institute
Department
Personal name
Akihiko Shimomura
Funding Source
Organization
None
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
Japan Institute for Health Security
Address
1-21-1 Toyama-cho, Shinjuku-ku, Tokyo, Japan
Tel
0332027181
ando.k@jihs.go.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
国立健康危機管理研究機構 国立国際医療センター(東京都)
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 23 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 07 | Month | 17 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 14 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 24 | Day |
Last follow-up date
| 2029 | 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
| 2025 | Year | 10 | Month | 20 | Day |
Last modified on
| 2025 | Year | 10 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068012
