A Phase II Prospective, Open-Label, Randomized, Multicenter Study of Kangfu Spray for the Prevention of Radiation-Induced Oral Mucositis in Patients With Oral Malignancies Receiving Intensity-Modulated Radiotherapy

This is a prospective, open-label, randomized, controlled, multicenter phase II study evaluating the efficacy and safety of Kangfu Spray for the prevention of radiation-induced oral mucositis in patients with histologically confirmed oral malignancies receiving intensity-modulated radiotherapy (IMRT), with or without concurrent platinum-based chemotherapy. Eligible participants will undergo definitive or postoperative adjuvant IMRT according to multidisciplinary team recommendations. Participants in the experimental group will receive Kangfu Spray prophylactically from the first day of radiotherapy until completion of radiotherapy, in addition to standard oral care. The primary endpoint is the incidence of severe radiation-induced oral mucositis, defined as World Health Organization (WHO) grade 3 or higher. Secondary endpoints include time to onset and duration of severe oral mucositis, incidence and duration of any oral mucositis, oral ulcer and pain scores, radiotherapy interruption, opioid analgesic use, nutritional indicators, quality of life, and safety. Exploratory analyses will evaluate lymphocytes, inflammatory factors, and microbiota in blood and saliva.

Sex

All

Minimum age

18 Years

Maximum age

80 Years

Inclusion Criteria:

* Histologically confirmed oral malignancy.
* Age 18 to 80 years.
* Karnofsky Performance Status (KPS) score \>=70.
* Planned to receive definitive or postoperative adjuvant intensity-modulated radiotherapy (IMRT), with or without concurrent chemoradiotherapy, after multidisciplinary team evaluation.
* Adequate organ function, including white blood cell count \>=2.0 x 10\^9/L, absolute neutrophil count \>=1.0 x 10\^9/L, platelet count \>=80 x 10\^9/L, hemoglobin \>=90 g/L, serum creatinine \<=1.5 x upper limit of normal (ULN) or creatinine clearance \>=50 mL/min, total bilirubin \<=1.5 x ULN, and AST/ALT \<=2.5 x ULN.
* Able to understand and comply with study procedures.
* Written informed consent provided.

Exclusion Criteria:

* Known allergy to Kangfu Spray or severe allergic predisposition.
* Uncontrolled immune-related oral mucosal disease or prior related immune mucosal disease.
* Pregnancy or breastfeeding.
* Prior radiotherapy to the head and neck region.
* Any severe concomitant disease or condition that, in the investigator's judgment, makes the participant unsuitable for participation.