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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo excipient spray | Placebo Comparator | A placebo spray consisting of the excipient formulation without superoxide dismutase, which is the same as the experimental group in appearance. |
|
| Superoxide dismutase containing skin spray | Experimental | A topical skin spray containing superoxide dismutase |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A topical superoxide dismutase skin spray | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From the start of radiotherapy to 4 weeks after completion of radiotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From the start of radiotherapy to 4 weeks after completion of radiotherapy. |
| Duration of grade ≥ 2 ARD between the two arms. |
| Measure | Description | Time Frame |
|---|---|---|
| Radiotherapy interruption rate | Radiotherapy interruption is defined as an unplanned prolongation of the radiotherapy schedule resulting in a delay of ≥5 days compared with the planned treatment schedule, excluding scheduled breaks. | Up to 8 weeks (from initiation to completion of radiotherapy) |
| Patient-reported skin symptoms from the Skindex-16 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xingchen Peng | Contact | +86 18980606753 | pxx2014@163.com | |
| Yu Min | Contact | 13108175138 |
| Name | Affiliation | Role |
|---|---|---|
| Xingchen Peng | Study Principal Investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sichuan University West China Hospital | Chengdu | Sichuan | 610041 | China |
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| ID | Term |
|---|---|
| D011855 | Radiodermatitis |
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D011832 | Radiation Injuries |
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|
| Placebo Spray | Other | 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. |
|
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. |
| 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. | 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. | From the start of radiotherapy to 4 weeks after completion of radiotherapy. |
The Skindex-16 is a commonly used tool to measure the effect of skin diseases on the skin-related QoL of patients. Skindex-16 consists of domain scores that assess how symptoms, emotions, and functioning from the skin issue affect the QOL of patients with acne. The overall score averages the 3 domain scores, all of which are normalized to a 0 to 100 scale, where 0 indicates that their skin condition has no impact on QOL and 100 represents maximal impact on QOL for the worse. |
| From 1 week before radiotherapy to 4 weeks after completion of radiotherapy. |
| Overall Health Status and Core Dimensions of Quality of Life | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) This instrument is a 30-item patient-reported outcome (PRO) measure designed to evaluate core aspects of health-related quality of life in cancer patients, including 5 functional scales (physical, role, cognitive, emotional, social), 3 symptom scales (fatigue, pain, nausea and vomiting), one global health status/quality of life scale, and 6 single-item symptom measures. Scores are linearly transformed to a range of 0-100. For the functional scales and the global health status scale, higher scores indicate better functional levels or quality of life; for the symptom scales/items, higher scores indicate greater symptom burden. | The total evaluation period is approximately 14 to 14.5 weeks. |
| Head and Neck Cancer-Specific Symptoms | The EORTC QLQ-H&N35 is a patient-reported outcome (PRO) instrument specifically designed to assess disease-related symptoms and treatment-related side effects in patients with head and neck cancer. It comprises 35 items, organized into seven multi-item subscales (pain, swallowing, senses, speech, social eating, social contact, and sexuality) and eleven single-item measures (such as dental problems, problems opening mouth, sticky saliva, coughing, etc.). All subscale and single-item scores are linearly transformed to a 0-100 scale using a standardized scoring algorithm. Interpretation of Scores: For all subscales and single items, higher scores represent more severe symptoms or greater symptom burden. | The total evaluation period is approximately 14 to 14.5 weeks. |
| Skin microbiome composition and diversity | Skin microbiome composition and diversity will be assessed as an exploratory endpoint using 16S rRNA gene sequencing. Skin swab samples will be collected from the irradiated skin area at baseline (before radiotherapy initiation) and at completion of radiotherapy. | Baseline and end of radiotherapy (approximately 8 weeks after radiotherapy initiation) |
| Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | Common Terminology Criteria for Adverse Events (CTCAE) 5.0 version. | From 1 week before radiotherapy to 4 weeks after completion of radiotherapy. |
| D014947 |
| Wounds and Injuries |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |