radiotherapy-induced oral mucositis in head and neck cancer
Conditions
Interventions
control group:NA
Sponsors
The Second Affiliated Hospital of Fujian University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Oral cancer, oropharyngeal cancer, laryngeal cancer, hypopharyngeal cancer and nasopharyngeal carcinoma diagnosed by pathology within 6 months before enrollment; 2. Radiotherapy (radiotherapy alone or radiotherapy after operation) is planned, and the total amount of planned radiotherapy is 60~70 Gy; 3. KPS score >= 70, and estimated survival time >= 6 months; 4. Aged 18 - 75 years (including 18 and 75 years), and the gender is not limited; 5. Informed consent and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Receiving induction chemotherapy, concurrent chemotherapy or other treatment measures, such as targeted drugs, immune checkpoint inhibitors and other tumor treatment schemes; 2. Severe oral diseases such as confirmed oral mucosal diseases, acute pulpitis, acute apicitis, oral mucositis caused by tumor, or repeated episodes of oral mucositis (more than 1 time / month) before radiotherapy; 3. Oral mucositis and viral stomatitis caused by other diseases and drugs; 4. Head and neck tumors diagnosed or suspected to have distant metastasis; 5. Recurrent head and neck tumors in situ; 6. Suffering from other malignant tumors; 7. There is unbearable cancer pain that needs analgesic treatment; 8. Combined with other serious primary diseases such as heart, liver, kidney, hematopoietic system, endocrine system, respiratory system, digestive system, or abnormal liver and kidney function (such as aminotransferase (AST or ALT) >= 2 times the upper limit of normal value and / or significant increase of total bilirubin and creatinine > 1.5 times the upper limit of normal value); Poor blood glucose control (glycosylated hemoglobin > 7.0%); 9. Unable to take drugs; 10. Positive pregnancy test, pregnant or lactating women, with pregnancy plan within half a year; 11. Have a history of allergy to the test drug components; 12. Long term heavy drinking (long term heavy drinking standard: drinking for more than 5 years, equivalent to alcohol volume: male >= 40 g/d, female >= 20 g/d, or having a history of heavy drinking within 2 weeks, equivalent to alcohol volume > 80 g/d) (alcohol volume (g) conversion formula: alcohol volume (mL) x ethanol content (%) x 0.8) and / or psychoactive substances, drug abuse and dependence history, drug abuse or reluctance to quit chewing tobacco products, betel nuts or smoking habits during the study; 13. Have mental retardation or mental disease; 14. Wearing orthodontic braces or fixators that may contact with ulcers; 15. Dental surgery is planned during the trial; 16. Participated in other clinical trials in recent 3 months; 17. The investigator thinks that it is not suitable to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of oral mucositis at all levels;Adverse events; | — |
Secondary
| Measure | Time frame |
|---|---|
| The occurrence time of oral mucositis at all levels;The area under the grading - time curve of oral mucositis at all levels;The area under the visual analogue scale score - time curve for oral pain during the study period;Healing time of oral mucositis;Changes in body weight before and after treatment;Weekly quality of life assessment;Changes in oral assessment guide scores weekly;Changes in Karnofsky performance score;Number of lidocaine drugs used;C-reaction protein;Eastern Cooperative Oncology Group score;Routine blood test;Urinary routine;liver function;renal function;12-lead electrocardiogram;Pregnancy test; | — |
Countries
China
Contacts
Public ContactDu Jian
The Second Affiliated Hospital of Fujian University of Traditional Chinese Medicine
Outcome results
None listed