Superoxide Dismutase Skin Spray for the Prevention of Acute Radiation Dermatitis in Head and Neck Cancer

Superoxide Dismutase Skin Spray for Reducing Acute Radiation Dermatitis in Patients With Head and Neck Cancer Undergoing Radiotherapy: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

To evaluate the efficacy and safety of superoxide dismutase skin spray for the reducing the acute radiation dermatitis in patients with head and neck malignancies undergoing radiotherapy.

Radiotherapy (RT) is a cornerstone treatment for patients with head and neck cancer and may be administered as definitive, adjuvant, or concurrent therapy with chemotherapy depending on disease stage and clinical indication. Despite its therapeutic benefits, RT is frequently associated with a range of acute toxicities, among which radiation dermatitis is one of the most common and clinically relevant adverse effects. Radiation-induced skin injury may present during or shortly after the course of radiotherapy and can significantly impact patient comfort, treatment adherence, and overall quality of life. Severe cases may lead to treatment interruption or dose modification, potentially compromising oncologic outcomes. The incidence of acute radiation dermatitis in patients with head and neck cancer has been reported to be high, with a substantial proportion of patients developing at least moderate-grade skin reactions during the course of radiotherapy. However, current preventive and therapeutic strategies remain limited, and no universally accepted standard of care has been established. Existing supportive measures are primarily empirical and have shown variable efficacy in reducing the severity or progression of skin toxicity. Superoxide dismutase (SOD) is an endogenous antioxidant enzyme with the ability to catalyze the dismutation of superoxide radicals into oxygen and hydrogen peroxide, thereby reducing oxidative stress-induced cellular damage. Given that oxidative stress is a key mechanism underlying radiation-induced skin injury, topical application of SOD-based formulations may provide a biologically plausible approach for mitigating radiation dermatitis. Based on this rationale, the present clinical trial is designed to investigate the efficacy and safety of a topical SOD skin spray in preventing and reducing acute radiation dermatitis in patients with head and neck cancer undergoing radiotherapy.

Inclusion Criteria:

1. Histologically confirmed malignant tumors of the head and neck without distant metastasis.
2. Scheduled to undergo either postoperative adjuvant radiotherapy or definitive radiotherapy, with or without concurrent chemotherapy.
3. Age 18-80 years at the time of consent.
4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
5. Signed informed consent form.
6. Adequate cognitive and reading abilities to complete the questionnaire.

Exclusion Criteria:

1. Pre-existing skin disease or open wounds in the irradiation field.
2. Have a history of head and neck radiotherapy.
3. Autoimmune or connective tissue disorders affecting skin.
4. Known allergy to any component of study formulations.
5. Any condition that, in the investigator's judgment, would interfere with study participation or outcome assessment.