Head and Neck Cancer
Conditions
Interventions
Lidocaine-Dexamethasone-Honey Group:The lidocaine-dexamethasone-honey mouthwash is composed of 20 ml lidocaine hydrochloride solution (0.1 g/5 ml), 1 ml dexamethasone solution (5 mg/1 ml), 10 g honey,
Control Group:The honey mouthwash is composed of 10 g honey and 250 ml sterile water for injection. Patients begin to use the mouthwash when oropharyngeal pain occurs during radiotherapy and the sever
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. diagnosed with HNC by histopathological examination, conforming to the diagnostic criteria with the Guidelines of Chinese Society of Clinical Oncology (CSCO) Head and Neck Cancer 2024; 2. 18-65 years old and of either gender; 3. planned to receive radical radiotherapy for the first time, with or without neoadjuvant chemotherapy, concurrent chemotherapy, adjuvant chemotherapy, targeted therapy, or immunotherapy; 4. Eastern Cooperative Oncology Group (ECOG) performance status = 3; 5. expected survival time = 12 months; 6. the type, amount, and frequency of food intake have not significantly changed compared with before a cancer diagnosis;
Exclusion criteria
Exclusion criteria: 1. allergy to lidocaine, dexamethasone, honey, or restricted to honey intake due to conditions such as diabetes; 2. with a contraindication to lidocaine, including Adams-Stokes syndrome, Wolff-Parkinson-White syndrome, severe heart block, and malignant hyperthermia; 3. precautions with dexamethasone, including hypertension, thrombosis, myocardial infarction, gastric and duodenal ulcers, recent visceral surgery, electrolyte imbalances and glaucoma; 4. current diagnosis of mental illness and severe cognitive impairment who are unable to fill in the questionnaires; 5. have visible cancerous ulcers or erosions at oral and pharyngeal regions; 6. have other non-tumor-related oropharyngeal pain, such as primary mouth opening difficulty, swallowing or eating, or other untreated primary oral diseases; 7. pregnant or breastfeeding; 8. be determined to be inappropriate for participation in the study by the clinical investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Numeric Rating Scale (NRS) pain score for the oropharyngeal during peri-radiotherapy; | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence and degree of oral mucositis during peri-radiotherapy;Symptom burden during peri-radiotherapy;Body Mass Index (BMI) during peri-radiotherapy;Hemoglobin level during peri-radiotherapy;Serum albumin level during peri-radiotherapy;Quality of life and patient satisfaction during peri-radiotherapy;The frequency of radiotherapy interruptions during peri-radiotherapy;Potential of Hydrogen (PH) of the oral cavity and detected species, detected levels and composition of oral microbiota; | — |
Countries
China
Contacts
Public ContactXiaoxia Zhang
West China Hospital of Sichuan University
Outcome results
None listed