Radiation-induced mucositis
Conditions
Interventions
High-dose group:MeiLianFuXin Liquid (GD-N1901
10mg/ml).Dosage and Administration: Oral gargle followed by swallowing. Dosage: 2 vials( 20 mL) per dose, 3 times daily. Duration: From the first dose after randomization until Day 14 (+3 days) after
Low-dose group:MeiLianFuXin Liquid (GD-N1901
5mg/mL).Dosage and Administration: Oral gargle followed by swallowing. Dosage: 2 vials( 20 mL) per dose, 3 times daily. Duration: From the first dose after randomization until Day 14 (+3 days) after t
Placebo group:MeiLianFuXin Liquid (GD-N1901
0mg/mL).Dosage and Administration: Oral gargle followed by swallowing. Dosage: 2 vials( 20 mL) per dose, 3 times daily. Duration: From the first dose after randomization until Day 14 (+3 days) after t
Sponsors
West China Hospital , Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Patients aged 18 to 80 years old (inclusive of 18 and 80 years old), both male and female. 2.Patients with histopathologically confirmed head and neck malignant tumors (including nasopharyngeal carcinoma) and no distant metastasis. 3.Patients with head and neck malignant tumors (including nasopharyngeal carcinoma) who develop Grade 1 oral mucositis during radical radiotherapy or postoperative adjuvant radiotherapy, with or without concurrent chemotherapy. 4.The radiotherapy modality must be static or dynamic intensity-modulated radiation therapy (IMRT), with a planned cumulative radiation dose of >= 60 Gy; the concurrent chemotherapy drug must be cisplatin. 5.ECOG performance status: 0-2. 6.The patient understands the study procedures and is willing to comply with the study protocol, voluntarily joins this study, and signs the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with a history of prior head and neck radiotherapy. 2. Patients who plan to use medications that may aggravate oral mucositis (such as anti-EGFR monoclonal antibodies, immune checkpoint inhibitors, etc.) after the initiation of radiotherapy. 3. Patients with pre-existing oral diseases prior to radiotherapy that, in the opinion of the investigator, may affect the efficacy evaluation of this trial, such as recurrent aphthous ulcers, primary herpetic stomatitis, oral lichen planus (erosive type), senile xerostomia, etc. 4. Patients with concurrent severe cardiac, pulmonary, hepatic, renal, digestive, hematopoietic, or nervous system diseases, acute infectious diseases, autoimmune diseases, HIV, or poorly controlled diabetes; or any other severe condition that, in the judgment of the investigator, may increase the risks of the study, interfere with study execution or data analysis, or render the subject unsuitable for enrollment for other reasons. (1) Severe heart failure (New York Heart Association (NYHA) functional class >= III). (2) Severe asthma: Uncontrolled despite treatment with high-dose inhaled corticosteroids/long-acting ß2-agonists. (Note: High-dose inhaled corticosteroids refer to budesonide > 800 µg/day, equivalent to budesonide/formoterol 160 µg/4.5 µg > 5 inhalations/day; or fluticasone propionate > 500 µg/day, equivalent to salmeterol/fluticasone propionate 50 µg/500 µg > 1 inhalation/day). (3) End-stage renal disease (ESRD): End-stage renal disease requiring dialysis. (4) Gastrointestinal bleeding within the past 3 months, gastrointestinal obstruction within the past 1 month, or gastrointestinal perforation within the past 1 month. (5) Ischemia or hemorrhagic stroke within the past 3 months. (6) History of allogeneic organ transplantation or systemic lupus erythematosus (SLE). (7) Positive for HIV antibody or positive for hepatitis C virus (HCV) antibody. (8) Glycated hemoglobin (HbA1c) > 8%. (9) Positive for syphilis antibody accompanied by positive TRUST and positive TPPA; or positive for hepatitis B surface antigen (HBsAg) with HBV DNA quantification > 2000 IU/mL. 5. Patients with major organ dysfunction, defined as meeting any of the following criteria:Hemoglobin = 2 × ULN;AST or ALT >= 2.5 × ULN;Serum creatinine > 1.5 × ULN. 6. Pregnant or lactating women. 7. Patients with an allergic constitution (e.g., known history of allergy to two or more medications) or known allergy to any component of the investigational product. 8. Patients with severe psychiatric disorders, or a current history of alcohol or drug abuse. [Alcohol abuse is defined as weekly alcohol consumption greater than 21 units/week for males and 14 units/week for females (1 unit = 360 mL of beer, 150 mL of wine, or 45 mL of liquor)]. 9. Patients who have participated in other clinical trials within the past 3 months. 10. Subjects who are judged by the investigator to be unsuitable for participation in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of severe oral mucositis; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to onset and duration of Grade 2 or higher oral mucositis;Changes in weekly oral and pharyngeal pain scores;Use of analgesic medications; | — |
Countries
China
Contacts
Public ContactPeng Xingchen
West China Hospital , Sichuan University
Outcome results
None listed