oral mucositis
Conditions
Interventions
Prevention group:From the first day of radiotherapy, rhGM-CSF was treated until the end of radiotherapy.
treatment group:Since the onset of grade I oral mucositis, patients were treated with RHGM-CSF until the end of radiotherapy.
Sponsors
The First Affiliated Hospital of China Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age 18 and above, no gender limitation; 2. They have fully understood the study and signed informed consent voluntarily, and are able to comply with the protocol during the study and complete all test procedures; 3. Radiotherapy for head and neck (total radiotherapy dose is about 70Gy); 4. Eastern Cooperative Oncology Group (ECOG) 0-1 score, with an expected survival time of more than 6 months; 5. No allergic history of Escherichia coli preparations 6. After assessment by attending physicians and researchers, important organ functions can withstand the treatment risk, and the baseline blood routine and biochemical indicators meet the following standards: hemoglobin >=90g/L; Neutrophil absolute count (ANC) >=1.5×10^9/L; White blood cell absolute count (WBC) >=3.0×10^9/L; Platelet (PLT) >=100×10^9/L; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <=2.5 times the normal upper limit (ULN) (ALT and AST <=5 times ULN if liver metastasis is present); Serum total bilirubin (TBIL) <=1.5 ULN; Serum creatinine (SCr) =1.5 times ULN; International Standardized Ratio (INR) <=2 TIMES ULN, or activated partial thrombin time (APPT) <=1.5 times ULN (except in patients receiving anticoagulant therapy).
Exclusion criteria
Exclusion criteria: 1. History of chronic oral ulcer and other chronic oral diseases; 2. Patients with serious concomitant diseases, including medical diseases that are not stable after treatment, or a history of neurological or psychiatric diseases (such as dementia or epilepsy), should not receive radiotherapy; 3. The site requiring treatment has received radiotherapy; 4. With malignant pleural effusion or malignant abdominal effusion, or accompanied by intestinal obstruction; 5. Pregnant or nursing women; 6. Patients expected to undergo major surgery during the study period; 7. Participated in clinical trials of other drugs within 4 weeks prior to enrollment; 8. Have a history of alcohol, drug or drug abuse in the past 1 year; 9. Allergic to the test drug preparation; 10. Subjects considered unsuitable for the study by the investigator for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of oral mucositis with grade 3 or above; | — |
Secondary
| Measure | Time frame |
|---|---|
| The situation of oral mucosa reflects;Degree of oral mucosa injury; | — |
Countries
China
Contacts
Public ContactQiao Qiao
The First Affiliated Hospital of China Medical University
Outcome results
None listed