Novel ROS-scavenging Nanoenzymes for the Treatment of Radiation Dermatitis in Patients With Head and Neck Cancer

Radiotherapy often leads to various complications, with radiation dermatitis being the most common side effect observed in the majority of tumor patients undergoing treatment. This condition not only affects a patient's appearance but, in severe cases, may even require the interruption of treatment.

Currently, there is no standard treatment for radiation dermatitis. In this study, the investigators have designed novel ROS-scavenging nanoenzymes, offering a potential new approach for preventing and treating radiation dermatitis.

This clinical trial aims to evaluate the effectiveness of these novel ROS-scavenging nanoenzymes in preventing radiation dermatitis in patients with head and neck cancer.

• ROS-scavenging Nanoenzymes (Drug): ROS-scavenging nanoenzymes are applied to the treatment area, once daily during radiotherapy.
• Standard of care (Behavioral): Standard of care

Primary outcomes

• The incidence of grade 2 or higher radiation dermatitis [From the start of radiotherapy to 2 weeks after completion of radiotherapy.]: Patients are assessed weekly for radiation dermatitis by an experienced radiation oncology nurse according to the Radiation Therapy Oncology Group (RTOG) criteria.

Secondary outcomes

• The maximum skin toxicity [From the start of radiotherapy to 2 weeks after completion of radiotherapy.]: The maximum grade of RTOG skin toxicity between 0 and 4.

Sex: All, ages: 18 Years to 80 Years

Inclusion Criteria:

1. Patients with a pathological diagnosis of non-metastatic head and neck malignant tumors;
2. Patients deemed suitable for high-dose radiotherapy, either as a primary treatment or as postoperative treatment following surgical resection.

Exclusion Criteria:

1. Eastern Cooperative Oncology Group performance status of >2;
2. Pre-existing skin rash, ulceration or open wound in the treatment area;
3. Inflammatory or connective tissue disorder of the skin;
4. History of head and neck radiotherapy.

• Xingchen Peng, Prof., Principal investigator, Sichuan University West China Hospital