Oral Mucositis
Conditions
Interventions
Single Arm:Sushu: Take 15 mL as per instructions, rinse mouth for 60 seconds then spit out, repeat every 4 hours
Sponsors
Nanjing Tianyinshan Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Participants aged 18 years or older, regardless of gender. 2.Patients with a confirmed diagnosis of malignant tumor based on histopathological or cytological examination. 3.ECOG performance status score 0–2; 4.Patients receiving antineoplastic therapy (including radiotherapy, chemotherapy, or ADC therapy, etc.) who have developed treatment-related oral mucositis of >= Grade 1 according to the WHO Oral Toxicity Scale. 5.Oral pain due to oral mucositis present and unresolved before study treatment on the day of enrollment and during the screening period. 6.The patient has given fully informed consent, participates voluntarily, and has signed the informed consent form; and agrees to actively cooperate with treatment, observation, and follow-up.
Exclusion criteria
Exclusion criteria: 1.Patients with known hypersensitivity to Sushu® Oral Mucosal Liquid Dressing or its components. 2.Patients with oral cancer; 3.Use of medications promoting oral mucosal healing (e.g., granulocyte-macrophage colony-stimulating factor and palifermin) within 2 weeks prior to screening. 4.Any other diseases or conditions that, in the investigator’s judgment, make the patient ineligible for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area Under the Curve (AUC) of Oral Mucosal Pain Score Within 0-4 Hours After Single Dose Administration;Area Under the Curve (AUC) of Oral Mucosal Pain Score During Multiple Dosing Period; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pain Intensity Difference (PID) Between Single Dose (0-4 Hours) and Multiple Dosing Period;Peak Pain Intensity Difference (PPID) Between Single Dose (0-4 Hours) and Multiple Dosing Period;Average Dysphagia Index During Single Dose (0-4 Hours) and Multiple Dosing Period;Percentage of Patients Achieving Oral Mucositis Grade Reduction and Time to Oral Mucositis Grade Reduction from Enrollment to End of ShuShu? Treatment;Rescue Analgesic Medication Use During Single Dose (0-4 Hours) and Multiple Dosing Period;Patient Perception of Use Experience (Film Formation Speed, Comfort, Foreign Body Sensation, Taste, Stinging Sensation) During Single Dose (0-4 Hours) and Multiple Dosing Period; | — |
Countries
China
Contacts
Public ContactChen Yingxia
Nanjing Tianyinshan Hospital
Outcome results
None listed