Radiochemotherapy-related oral mucositis in patients with head and neck tumors
Conditions
Interventions
Treatment Group:Gargling with Kangfuxin Liquid combined with spraying Kai-Hou-Jian Spray in the oral cavity
Sponsors
Eye & ENT Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18–65 years, regardless of gender. 2. Patients with head and neck tumors who have developed radiochemotherapy-related oral mucositis with a grade = Grade 3 according to the WHO grading system, RTOG grading system, NCI-CTCAE (radiotherapy) grading system, and NCI-CTCAE (chemotherapy) grading system. 3. Voluntarily agree to receive the study treatment regimen and sign the informed consent form (ICF). 4. All women of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose. Male and female subjects of reproductive potential must agree to use reliable contraceptive measures (e.g., hormonal contraception, barrier contraception, or abstinence) with their partners throughout the entire study period and for at least 6 months after the last administration of the study drug. 5. ECOG performance status of 0 or 1, and deemed capable of tolerating chemotherapy and radiotherapy based on comprehensive assessment. 6. Subjects must have adequate organ function, defined as follows: Liver function: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) 1.5 × ULN). Bone marrow function: Absolute neutrophil count (ANC) = 1.5 × 10^9/L; platelet count (PLT) = 75 × 10^9/L; hemoglobin (Hb) = 90 g/L. Coagulation function: Prothrombin time (PT) or international normalized ratio (INR) = 1.5 × ULN.
Exclusion criteria
Exclusion criteria: 1. History of severe autoimmune diseases, uncontrolled diabetes mellitus, or active psychiatric disorders. 2. Complicated with severe diseases of the liver, kidneys, cardiovascular system, or hematopoietic system, or with psychological/psychiatric disorders. 3. Complicated with diseases that may affect efficacy evaluation, including but not limited to pneumonia, bronchitis, suppurative tonsillitis, infectious laryngitis, and bacterial otitis media. 4. Currently receiving or expected to concomitantly receive the following treatments that may interfere with study evaluation during the trial period (including but not limited to): 1) Chinese medicinal preparations or decoctions for the treatment of acute pharyngitis or sore throat, such as Yanyan Chongji (Pharyngitis Granules), Qingyan Diwan (Throat-Clearing Dropping Pills), and Wanying Jiaonang (Wanying Capsules). 2) Chemical medicinal preparations for the treatment of acute pharyngitis, such as Cetylpyridinium Chloride Buccal Tablets and Lysozyme Buccal Tablets. 3) Systemic antibiotics, antiviral drugs, glucocorticoids, and other related therapies. 5. Prior use of analgesics or other Chinese and Western medicines for the treatment of acute pharyngitis or sore throat before screening. 6. A history of recurrent oral mucositis (OM) or OM caused by other diseases or drugs. 7. Pregnant or lactating women, or women planning to become pregnant during the study period. 8. Known or suspected allergy to any component of the study drugs (Kaihoujian Spray, Kangfuxin Liquid), or subjects with an allergic diathesis. 9. A history of drug abuse or dependence, alcoholism, or drug addiction. 10. Patients who have participated in other interventional clinical trials within 30 days prior to screening. 11. Presence of clinically significant electrocardiogram (ECG) abnormalities as assessed by the investigator, making the subject unsuitable for study participation. 12. Any other conditions judged by the investigator to be inappropriate for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Grading of the severity of oral mucositis;Severity of Oral Pain;Life quality; | — |
Secondary
| Measure | Time frame |
|---|---|
| Oral Saliva pH Value;Weight;Water intake; | — |
Countries
China
Contacts
Public ContactLei Tao
Eye & ENT Hospital, Fudan University
Outcome results
None listed