Skin injure
Conditions
Interventions
Control group:Biafine
Experimental group:Biafine combined with AKK
Sponsors
Jintang County First People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Patients must meet all of the following criteria to be selected: 1. Patients with high-dose radiotherapy for head and neck tumors (>=60Gy); 2. Age>=18 years old, =3 months 6. Good function of major organs, that is, relevant examination indicators meet the following requirements within 14 days before randomization (no blood transfusion or blood products, no hematopoietic stimulating factors, no albumin or blood products): Routine blood examination: hemoglobin >=80g/L; Neutrophil count> 1.5×10^9/L; Platelet count >=90×10^9/L; Biochemical examination: total bilirubin =50 mL/min (Cockcroft-Gault formula); 7. Patients of childbearing potential (regardless of gender) must accept effective medical contraception during the study period and within 6 months after the end of dosing; 8. Patients voluntarily join this study, sign the informed consent form, have good compliance, and the patient and his family agree to cooperate with follow-up and image collection of skin lesions;
Exclusion criteria
Exclusion criteria: Patients cannot be enrolled if they meet any of the following criteria: 1. Patients with cognitive dysfunction that prevents them from understanding the content of the study. 2. The patient has a history of malignancy that has received radiotherapy (at least 5 years before enrollment). 3. History of antibiotic or antifungal use within 1 month. 4. Patients who have been treated with other bacterial liquid products. 5. Have participated in clinical trials involving bacterial therapy. 6. Any abnormalities in the irradiated field such as scarring, permanent body art (e.g., tattoos) that, in the opinion of the investigator, would preclude the observation of local reactions in the irradiated field. 7. History of probiotic allergy, or known allergy, hypersensitivity, or intolerance to the study formulation, including any excipients. Previous history of severe allergies to drugs, foods, and immune preparations, such as anaphylactic shock, allergic laryngeal edema, allergic dyspnea, allergic purpura, thrombocytopenic purpura, local allergic necrosis reaction (Arthus reaction), etc. 8. Immunosuppressive drug users. 9. Patients with symptomatic or rapidly progressing central nervous system metastases, extensive lung metastases leading to dyspnea; Patients with tumors approaching or invading major blood vessels or nerves. 10. Patients with unwell-controlled cardiac clinical symptoms or diseases, such as: heart failure above NYHA grade 2, unstable angina, myocardial infarction within 1 year, clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention. 11. For female subjects: pregnant or lactating women. 12. Patient has active tuberculosis, bacterial or fungal infection (grade =2, based on NCI-CTCAE 5.0), or HIV infection. 13. Patients with a history of psychotropic substance abuse who cannot abstain or have mental disorders. 14. Subjects have any active autoimmune disease or history of autoimmune disease (such as, but not limited to: uveitis, enteritis, hypophysitis, nephritis, hyperthyroidism, hypothyroidism; Subjects with vitiligo or asthma in childhood who have been completely relieved and do not need any intervention in adulthood can be included; Asthma subjects requiring bronchodilators for medical intervention cannot be included). 15. History of substance abuse or known medical, psychological, or social conditions, such as a history of alcohol or drug abuse. 16. Subject has a pregnancy plan from the screening period to 12 months after the end of the last treatment. 17. Has a concomitant disease that seriously endangers the safety of the patient or affects the patient's completion of the study, in the judgment of the investigator. 18. Other situations that are not suitable for enrollment as judged by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Radiation field skin conditions, including lesion severity, coloration, edema, and dermal thickening; | — |
Countries
China
Contacts
Public ContactLei zhang
Jintang County First People's Hospital; West China Hospital, Sichuan University
Outcome results
None listed