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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат A topical superoxide dismutase skin spray
  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 i
• Другое Placebo Spray
  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 ski

Первичные конечные точки

• Incidence of grade ≥ 2 ARD [Срок оценки: From the start of radiotherapy to 4 weeks after completion of radiotherapy]

Вторичные конечные точки (4)

• Time to onset of grade ≥ 2 ARD between the two arms. [Срок оценки: From the start of radiotherapy to 4 weeks after completion of radiotherapy.]
• Duration of grade ≥ 2 ARD between the two arms. [Срок оценки: From the start of radiotherapy to 4 weeks after completion of radiotherapy.]
• Maximum dermatitis grade [Срок оценки: From the start of radiotherapy to 4 weeks after completion of radiotherapy.]
• Grade ≥3 radiation dermatitis incidence [Срок оценки: From the start of radiotherapy to 4 weeks after completion of radiotherapy.]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Профилактика

Центры проведения

Китай · 1 центр

• Sichuan University West China Hospital — Чэнду

Идентификаторы

NCT: NCT07704372 · 2026(819)

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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