breast cancer
Conditions
Interventions
control group:Normal saline
Intervention group:Dexamethasone combined with lidocaine mouthwash
Sponsors
The Second Affiliated Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 - 80 years old. 2. Invasive breast cancer confirmed by clinical pathology. 3. Initial chemotherapy regimen: pegylated liposomal doxorubicin + Cyclophosphamide (AC regimen). 4. Eastern Cooperative Oncology Group ( ECOG ) performance status score of 0-2. 5. Expected survival time of more than 6 months. 6. All subjects have signed an informed consent form and are willing to self-complete the questionnaire or complete it with assistance. 7. No oral lesions before chemotherapy. 8. Patients with normal heart, liver and kidney function.
Exclusion criteria
Exclusion criteria: 1. The subjects did not understand and refused to sign the informed consent. 2. Subjects with active stomatitis, oral mucositis or oral ulcer before enrolment. 3. Subjects with severe or uncontrolled diseases, including diabetes. 4. Subjects who need to use corticosteroids or other immunosuppressive drugs. 5. Subjects with obvious heart, liver and kidney function damage 6. Allergic to dexamethasone and lidocaine. 7. The subject has mental or behavioural abnormalities and is unable to cooperate with the study. 8. The subject is pregnant, breastfeeding, or at risk of pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of grade 2 or above OM.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of OM at all levels.;Duration of OM;Time of appearance of OM;Severity of oral pain;Duration of oral pain;Adverse event; | — |
Countries
China
Contacts
Public ContactHaixia Jia
The Second Affiliated Hospital of Guangzhou Medical University
Outcome results
None listed