Breast cancer
Conditions
Interventions
The following dental interventions will be performed: evaluation of the oral environment, dental calculus removal, professional mechanical tooth cleaning (PMTC), toothbrushing instruction, tongue coat
Sponsors
Japan Institute for Health Security
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients diagnosed with breast cancer eligible for Dato-DXd under Japanese insurance coverage and scheduled to receive Dato-DXd treatment.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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). | — |
Countries
Japan
Contacts
Public ContactKenju Ando
Japan Institute for Health Security Department of Breast and Medical Oncology, National Center for Global Health and Medicine
Outcome results
None listed