Drug induced oral lesions
Conditions
Interventions
Traditional Chinese Medicine Group:Kou-Yan-Ning for external use
Sponsors
The First Affiliated Hospital of Zhejiang Chinese Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. older than 18 years old, regardless of gender; 2. patients who are receiving precision antitumor drugs (including epidermal growth factor receptor antagonists, vascular endothelial growth factor receptor tyrosine kinase inhibitors, immune checkpoint inhibitors, etc.); 3. meet the diagnostic criteria for oral mucositis of who oral toxicity scale grade III; 4. the general condition is good, KPS > 60 points, and the estimated survival time is > 3 months; 5. the functional level of major organs should meet the following criteria: 1) blood routine examination criteria should meet: ANC = 1.5 × 109/l, PLT = 80 × 109/l, Hb = 90g/l 2) biochemical examination should meet the following criteria: TBIL < 1.5 × ULN, alt, AST < 2.5 × ULN subjects with liver metastasis can be < 5 × ULN, bun and Cr = 1 × ULN or endogenous creatinine clearance = 50ml/min (Cockcroft Gault formula); 6. the subjects voluntarily joined the study, signed the informed consent, had good compliance, and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1. there are other lesions in the mouth and esophagus or a history of drug contact allergy; 2. have received radiotherapy, chemotherapy or any other drugs that may cause oral mucositis within 4 weeks before the start of study treatment; 3. uncontrolled infection and / or metabolic disease; 4. abnormal coagulation function, or known hereditary or acquired bleeding tendency and thrombophilia; 5. the investigator judges other situations that may affect the conduct of clinical research and the judgment of research results. 6. those who have serious oral ulcer, oral infection, oral lichen planus and oral mucosa leukoplakia before the application of precision antitumor drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| classification of oral mucositis;Changes of NRS at rest and during diet;Effective time;Total effective rate; | — |
Countries
China
Contacts
Public ContactShu Qijin
The First Affiliated Hospital of Zhejiang Chinese Medical University
Outcome results
None listed