breast cancer breast cancer, stomatitis
Conditions
Interventions
Study arm: mouthwash with steroid mouthwash
Control arm: mouthwash with water
Sponsors
Kuba Sayaka
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients diagnosed with invasive breast cancer by needle biopsy or surgery 2) Patients who are scheduled to receive AC or EC/AC or EC + pembrolizumab/dose dense AC or dose-dense EC/TC therapy 3) Patients who can complete the patient diary and questionnaire in the ePRO 4) Persons with a PS of 0-1 5) Persons aged between 18 and 80 years at the time consent is obtained. 6) Persons who have given written consent to participate in the study.
Exclusion criteria
Exclusion criteria: (1) Persons with breast cancer metastasis or recurrence (2) Persons with oral mucositis before treatment (3) Persons with oral wounds caused by dentures (4) Women with pregnant or lactating (5) Persons deemed inappropriate for inclusion in the study by the principal investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the incidence of all-grade stomatitis using electric patient-reported outcomes (ePRO) | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients with moderate or severe oral mucositis assessed by ePRO, duration of oral mucositis assessed by ePRO, percentage of patients with total and grade 2 or higher oral mucositisassessed by physician, QoL, percentage of patients who discontinued, postponed or reduced chemotherapy during the study participation period, mouthwash adherence, and oral infection, other adverse events of grade 3 or higher, and related items of health economic evaluation. | — |
Contacts
Public ContactSayaka Kuba
Nagasaki University Hospital
Outcome results
None listed