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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
140
Patients are instructed to apply a topical superoxide dismutase-containing spray evenly to the entire radiotherapy-treated skin area, approximately 3 sprays per application, five times daily. Treatment is initiated at the start of radiotherapy and continued until the occurrence of grade ≥2 radiation dermatitis or up to one week after completion of radiotherapy, whichever occurs first. Patients are instructed to keep the irradiated skin clean and dry and to avoid the use of other topical agents in the treatment area.
Patients are instructed to apply a placebo excipient spray without superoxide dismutase evenly to the entire radiotherapy-treated skin area, approximately 3 sprays per application, five times daily, following the same schedule as the experimental group. Treatment is initiated at the start of radiotherapy and continued until the occurrence of grade ≥2 radiation dermatitis or up to one week after completion of radiotherapy, whichever occurs first. Patients are instructed to keep the irradiated skin clean and dry and to avoid the use of other topical agents in the treatment area.
Sichuan University West China Hospital
Chengdu, Sichuan, China
Incidence of grade ≥ 2 ARD
Patients are assessed weekly for radiation dermatitis by an experienced radiation oncology nurse according to the Radiation Therapy Oncology Group (RTOG) scale. The RTOG scale categorizes acute skin toxicity into grades 0-4, with the higher the grade the more severe the patient's acute radiation dermatitis. Grade 0 means no change over baseline. Grade 1 means follicular, faint, or dull erythema; epilation, dry desquamation, or decrease in sweating. Grade 2 means tender, bright erythema; patchy, moist desquamation or moderate edema. Grade 3 means confluent, moist desquamation other than skin folds; pitting edema. Grade 4 means ulceration, hemorrhage, necrosis.
Time frame: From the start of radiotherapy to 4 weeks after completion of radiotherapy
Time to onset of grade ≥ 2 ARD between the two arms.
Time from the first day of radiotherapy to the first determination of grade 2 or higher radiation dermatitis.
Time frame: From the start of radiotherapy to 4 weeks after completion of radiotherapy.
Duration of grade ≥ 2 ARD between the two arms.
The first determination of grade 2 or higher radiation dermatitis to the first instance of grade 1 or 0 radiation dermatitis, without a subsequent instance of grade 2 or higher radiation dermatitis. Patients without observed grade 2 or higher radiation dermatitis were assigned a duration of 0 days.
Time frame: From the start of radiotherapy to 4 weeks after completion of radiotherapy.
Maximum dermatitis grade
The maximum grade of RTOG skin toxicity between 0 and 4.
Time frame: From the start of radiotherapy to 4 weeks after completion of radiotherapy.
Grade ≥3 radiation dermatitis incidence
Patients are assessed weekly for radiation dermatitis by an experienced radiation oncology nurse according to the Radiation Therapy Oncology Group (RTOG) scale. The RTOG scale categorizes acute skin toxicity into grades 0-4, with the higher the grade the more severe the patient's acute radiation dermatitis. Grade 0 means no change over baseline. Grade 1 means follicular, faint, or dull erythema; epilation, dry desquamation, or decrease in sweating. Grade 2 means tender, bright erythema; patchy, moist desquamation or moderate edema. Grade 3 means confluent, moist desquamation other than skin folds; pitting edema. Grade 4 means ulceration, hemorrhage, necrosis.
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Time frame: From the start of radiotherapy to 4 weeks after completion of radiotherapy.