Radiochemotherapy-related oral mucositis in patients with head and neck tumors
Conditions
Interventions
Experimental 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. Age: 18 - 65 years old, gender not restricted. 2. Patients with head and neck tumors who have received radiotherapy or chemotherapy should have a grade of oral mucositis related to the treatment that is less than or equal to WHO grade 3, RTOG grade 3, NCI-CTCAE (radiotherapy) grade 3, and NCI-CTCAE (chemotherapy) grade 3. 3. Voluntary to accept the treatment plan of this study and sign the informed consent form. 4. All fertile women must have a negative serum pregnancy test within 7 days before the first administration, and fertile male and female participants must agree to use reliable contraceptive measures (hormonal contraception, barrier contraception, or abstinence) with their partners throughout the study period and for at least 6 months after the last use of the test drug. 5. ECOG score: 0 or 1, and considered capable of tolerating chemotherapy and radiotherapy by comprehensive assessment. 6. The subjects must have adequate organ functions, as defined below: Liver function: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 50 mL/min (serum creatinine > 1.5 times ULN); Bone marrow function: Absolute neutrophil count (ANC) >= 1.5 x 10^9/L, platelet count (PLT) >= 75 x 10^9/L, hemoglobin (Hb) >= 90 g/L; Coagulation function: Prothrombin time (PT) or international normalized ratio (INR) <= 1.5 times ULN.
Exclusion criteria
Exclusion criteria: 1. Suffering from severe autoimmune diseases, uncontrolled diabetes, or active psychosis. 2. Having severe liver, kidney, cardiovascular and hematological diseases, or mental/psychiatric disorders. 3. Having diseases that may affect the evaluation of the treatment outcome, including but not limited to pneumonia, bronchitis, suppurative tonsillitis, infectious laryngitis, bacterial otitis media. 4. Currently using or expected to use during the trial the following treatments that may affect the evaluation of the trial (including but not limited to): (1) Chinese herbal preparations or decoctions with the effect of treating acute pharyngitis or sore throat, such as Xianyuanni Granules, Qingyan Dihuan Pills, Wanyi Capsules, etc. (2) Chemical preparations with the effect of treating acute pharyngitis, such as Xiaopi Chloramphenicol Lozenges, Solysin Capsules, etc. (3) Systemic antibiotics, antiviral drugs, glucocorticoids, etc. for treatment. 5. Have used analgesics or other Chinese or Western drugs for the treatment of acute pharyngitis or sore throat before the screening. 6. Have had recurrent OM in the past, or OM caused by other diseases or drugs. 7. Pregnant women or lactating women, or those planning to become pregnant during the study. 8. Known or suspected to be allergic to any components of the test drugs (Kaiyoutai Spray, Huiguanxin Solution), or having an allergic constitution. 9. Have a history of drug abuse or dependence, alcoholics, drug users. 10. Have participated in other interventional clinical trials within 30 days before screening. 11. Have been evaluated by the researcher as having clinically significant electrocardiogram abnormalities and not suitable for participating in this study. 12. The researcher judges that there are any circumstances that are not suitable for participating 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