Radiation-induced oral mucositis and radiotherapy-related dysfunction
Conditions
Interventions
Phase I: 0.15 mol/L Lithium Salt Hydrogel Cohort:Lithium salt hydrogel (lithium carbonate concentration 0.15 mol/L, containing PVA and citric acid, 3 ml), applied once daily after dinner during radiot
Phase I: 0.3 mol/L Lithium Salt Hydrogel Cohort:Lithium salt hydrogel (lithium carbonate concentration 0.3 mol/L, containing PVA and citric acid, 3 ml), applied once daily after dinner during radiothe
Phase I: 0.5 mol/L Lithium Salt Hydrogel Cohort:Lithium salt hydrogel (lithium carbonate concentration 0.5 mol/L, containing PVA and citric acid, 3 ml), applied once daily after dinner during radiothe
Phase I: 0.75 mol/L Lithium Salt Hydrogel Cohort:Lithium salt hydrogel (lithium carbonate concentration 0.75 mol/L, containing PVA and citric acid, 3 ml), applied once daily after dinner during radiot
Phase I: 1.0 mol/L Lithium Salt Hydrogel Cohort:Lithium salt hydrogel (lithium carbonate concentration 1.0 mol/L, containing PVA and citric acid, 3 ml), applied once daily after dinner during radiothe
Phase II: Trial Group (Lithium Salt Hydrogel):Lithium salt hydrogel (optimal dose determined from Phase I results, exact concentration not specified in protocol, containing PVA and citric acid, differ
3 ml), applied once daily after dinner during radiotherapy to oral mucosa, with no food or water intake for 30 minutes
Phase II: Placebo Group (PVA Hydrogel):PVA hydrogel (without lithium carbonate, otherwise identical composition
Sponsors
West China Hospital of Stomatology, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Head and neck malignant tumors (nasopharyngeal carcinoma, oral cancer, laryngeal cancer, etc.) confirmed by histopathology, without distant metastasis; 2. Age >=18 years old, =60 mL/min) and bone marrow functions (white blood cells >=3.0×10^9/L, platelets >=80×10^9/L, hemoglobin >=80g/L); 6. Voluntarily sign the informed consent form and commit to cooperating to complete the entire follow-up process.
Exclusion criteria
Exclusion criteria: 1. There is a history of radiotherapy to the head and neck or concurrent radiotherapy to other parts of the body; 2. Known to be allergic to lithium salts, polyvinyl alcohol (PVA), or other components of the gel, or have a severe allergic constitution; 3. Suffering from severe kidney disease (chronic kidney disease stage 3 or above), severe cardiovascular disease (heart failure, severe arrhythmia, etc.), myasthenia gravis, Parkinson's disease or epilepsy; 4. Have taken or are currently taking diuretics, non-steroidal anti-inflammatory drugs or other medications known to interact with lithium salts in the recent period (within 3 months); 5. Combined with other malignant tumors, severe infections or mental disorders, unable to cooperate with the trial; 6. Pregnant and lactating women; 7. Other circumstances that the researcher deems unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hydrogel-related adverse events (Phase II);Hydrogel-related adverse events (Phase I);Incidence of SOM (WHO grade >=3)(Phase II);Incidence of SOM (WHO grade >=3)(Phase I); | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life(Phase II);Taste Function(Phase II);Weight (Phase II);Taste Function(Phase I);Incidence of dry mouth (Phase II); | — |
Countries
China
Contacts
Public ContactXu Xin
West China Hospital of Stomatology, Sichuan University
Outcome results
None listed