Radiation-induced oral mucositis (RIOM) is an inevitable acute complication in radiotherapy for head and neck malignancies, characterized by a complex pathogenesis involving multiple biological processes. According to the latest data from the International Agency for Research on Cancer (IARC), approximately 650,000 new cases of head and neck cancers are diagnosed globally each year, with about 70% of patients undergoing radiotherapy. RIOM develops through a multistep pathophysiological cascade, including initiation of mucosal injury, signaling amplification, inflammatory response, ulceration, and eventual healing. Ionizing radiation induces DNA damage in oral mucosal epithelial cells, triggering increased apoptosis. This cellular injury promotes the activation and release of pro-inflammatory mediators such as tumor necrosis factor-α (TNF-α), interleukin-1β (IL-1β), and interleukin-6 (IL-6), compromising the integrity of the mucosal barrier and ultimately leading to ulcer formation. Current clinical management of RIOM remains largely supportive, relying on oral hygiene, nutritional supplementation, and pain control, with no effective prophylactic agents available. Despite extensive research into potential interventions internationally, no drugs specifically approved by the FDA or NMPA for the prevention of RIOM have reached the market. This significant unmet clinical need calls for urgent scientific and therapeutic advancement. This study aims to evaluate the therapeutic efficacy and safety profile of aerosolized exosomes derived from mesenchymal stem cells in the prevention and treatment of radiation-induced oral mucositis in patients receiving radiotherapy for head and neck cancers. The ultimate objective is to establish a novel and effective therapeutic strategy for clinical application.
Histologically or cytologically confirmed malignant tumor of the head and neck;
Age 18-75 years;
Scheduled to receive radical radiotherapy with a total planned dose of ≥60 Gy, with radiation fields including the oral cavity and/or oropharynx;
Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2 and a life expectancy of ≥6 months.
Previous radiotherapy to the head and neck region;
Head and neck surgery within the preceding 4 weeks;
Current participation in another clinical trial, or participation in another interventional study within the past 4 weeks;
Significant cardiovascular disease, including unstable angina, myocardial infarction within the past 6 months, severe arrhythmia, or heart failure (NYHA Class III-IV);
Parallel
mesenchymal stem cell-derived exosomes
DrugMesenchymal Exosome Administration Protocol: 1. Administration Timing: Begin 7 days prior to radiotherapy initiation and continue until 14 days post-radiotherapy completion. 2. Preparation: Remove the exosome vial, open the cap, add 5mL of saline solution, and secure the spray cap. 3. Administration Frequency: 3 times daily (30 minutes after breakfast, lunch, and dinner). 4. Dosage: Approximately 1.5mL per spray. 5. Administration Method: Oral spray. Evenly spray onto the oral mucosal surface. Avoid eating or rinsing for 20 minutes after administration.
The incidence of grade ≥3 radiation-induced oral mucositis
The primary endpoint is defined as the proportion of patients who develop grade 3 or higher radiation-induced oral mucositis (RIOM) from the start of radiotherapy until 90 days after the completion of radiotherapy. RIOM was graded according to the WHO oral toxicity scale criteria: Grade 0: No changes in the oral mucosa; Grade 1: Erythema of the oral mucosa with mild pain, not requiring analgesics; Grade 2: Patchy mucositis with serous exudate, moderate pain, usually not requiring analgesics; Grade 3: Confluent mucositis with severe pain requiring analgesics; Grade 4: Ulceration, hemorrhage, or necrosis, with intense pain affecting oral intake.
Incidence rate of RIOM at any level
Assess the difference in the proportion of patients experiencing any grade (Grade 1 or higher) of RIOM between the intervention group and the control group to evaluate the overall preventive efficacy of the intervention.
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First Affiliated Hospital of Guangxi Medical University
Lead sponsor
LiuZhou People's Hospital
Collaborator
First People's Hospital of Yulin
Collaborator
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