Oral mucositis Mucous membrane disorder
Conditions
Interventions
In addition to conventional oral care focusing on moisturization and the use of mucosal protective agents (such as Episil oral liquid), the investigational device will be applied to affected teeth tha
Sponsors
Omori Kazuhiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The subjects of this study are limited to those who meet all of the following criteria: 1) Breast cancer patients undergoing cancer chemotherapy (including molecular targeted therapy and immune checkpoint inhibitors) at the participating research facilities. 2) Patients who have not developed oral candidiasis. 3) Patients with contact between their teeth and oral mucosa. 4) Patients aged 18 years or older at the time of consent acquisition. 5) Patients with an ECOG Performance Status (PS) of 0 or 1. 6) Patients who are functionally capable of oral intake of food.
Exclusion criteria
Exclusion criteria: Subjects meeting any of the following criteria will be excluded from this study: 1) Patients undergoing or scheduled to undergo head and neck radiotherapy, including those who have received it as a prior treatment. 2) Patients with fewer than 10 teeth. 3) Patients using dentures. 4) Patients with allergies to antiseptic CPC or resin. 5) Patients who are pregnant or may be pregnant. 6) Patients currently using or scheduled to use medical narcotics, opioid formulations, or oral steroid ointments (such as dexamethasone). 7) Patients with planned dental treatments. 8) Patients who are unable or unwilling to perform the required assessments under physician supervision. 9) Patients deemed unsuitable for participation in this clinical trial by the principal or sub-investigator due to clinical, social, or conflict-of-interest considerations.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The subcriteria for oral mucositis according to CTCAE v3.0. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) The same evaluation items as the primary evaluation items mentioned above during the continuation treatment phase 2) Grades of oral mucositis, oral pain, and related symptoms (evaluated based on CTCAE v5.0/MedDRA/J v25.1) 3) QOL assessment [Patient-reported outcomes]: PRO-CTCAE v1.0 #3a, #3b, EORTC QLQ-OH15 #35, and pain NRS for the affected area 4) The location and timing of the onset of oral mucositis 5) Subgroup analysis by chemotherapy regimen focusing on prevention of onset/pain relief 6) Status of chemotherapy completion 7) Number of oral anti-inflammatory and analgesic tablets taken as needed (patient diary) 8) Number of rescue applications of oral steroid ointment (patient diary) 9) Number of applications of Episil reagent (patient diary) 10) Technical efficacy based on procedure-related surveys 11) Patient preferences regarding the investigational treatment (patient-reported outcomes) | — |
Contacts
Public ContactKazuhiro Omori
Okayama University Hospital
Outcome results
None listed