Grade 1-2 oral mucositis induced by EGFRI
Conditions
Interventions
TCM group :Following each meal, the oral cavity shall be cleansed with plain water. Subsequently, 15 mL of Kou-yan-nign shall be administered and retained in the oral cavity for 5 minutes before expul
active control group:Following each meal, the oral cavity shall be cleansed with plain water. Subsequently, 15 mL of compound chlorhexidine gargle shall be administered and retained in the oral cavit
Sponsors
The First Affiliated Hospital of Zhejiang Chinese Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 years or older, regardless of gender; 2. Patients with solid tumors receiving EGFRIs therapy; 3. Meeting the diagnostic criteria for Grade 1-2 oral mucositis according to the WHO Oral Toxicity Scale; 4. Conforming to the pattern of excess-heat syndrome in traditional Chinese medicine; 5. In good general condition with an ECOG score of 0-2 and an expected survival period = 3 months; 6. Voluntarily participating in this clinical study and providing informed consent prior to any study-specific procedures.
Exclusion criteria
Exclusion criteria: 1) Presence of severe oral infections, oral lichen planus, Behçet's disease, herpetic stomatitis, or other oral or pharyngeal lesions, or a history of drug contact allergies; 2) Use of medications for treating oral mucositis, such as sodium bicarbonate mouthwash, chlorhexidine mouthwash, hormonal ointments, or antibiotics, within one week prior to the start of the study; 3) Use of oral non-steroidal anti-inflammatory drugs or other pain relievers, or topical analgesics such as lidocaine mouthwash or gel, to alleviate pain caused by oral mucositis within one week prior to the start of the study; 4) Reduction or discontinuation of EGFRIs treatment; 5) Occurrence of other grade 1-2 or higher adverse reactions related to antitumor therapy, aside from oral mucositis; 6) Receipt of radiotherapy, chemotherapy, or any other medications that may cause oral mucositis within four weeks prior to the start of the study treatment; 7) Other circumstances deemed by the investigator as potentially affecting the conduct of the clinical study or the interpretation of study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the efficacy rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| OHIP-14 score;Changes in the Grading of Associated Symptoms (e.g., Pain, Paresthesia, Dietary Intake, etc.);Safety;oral mucositis recurrence rate; | — |
Countries
China
Contacts
Public ContactQijin Shu
The First Affiliated Hospital of Zhejiang Chinese Medical University
Outcome results
None listed