Superoxide Dismutase Skin Spray for the Prevention of Acute Radiation Dermatitis in Head and Neck Cancer
2026年7月9日 更新者：Xingchen Peng、West China Hospital
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (估计的)
140
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Xingchen Peng
- 电话号码：+86 18980606753
- 邮箱：pxx2014@163.com
研究联系人备份
- 姓名：Yu Min
- 电话号码：13108175138
学习地点
-
-
Sichuan
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Chengdu、Sichuan、中国、610041
- Sichuan University West China Hospital
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接触：
- Xingchen Peng
- 电话号码：+86 18980606753
- 邮箱：pxx2014@163.com
-
接触：
- Yu Min
- 电话号码：13108175138
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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安慰剂比较：Placebo excipient spray
A placebo spray consisting of the excipient formulation without superoxide dismutase, which is the same as the experimental group in appearance.
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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.
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实验性的：Superoxide dismutase containing skin spray
A topical skin spray containing superoxide dismutase
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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.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Incidence of grade ≥ 2 ARD
大体时间：From the start of radiotherapy to 4 weeks after completion of radiotherapy
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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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From the start of radiotherapy to 4 weeks after completion of radiotherapy
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Time to onset of grade ≥ 2 ARD between the two arms.
大体时间：From the start of radiotherapy to 4 weeks after completion of radiotherapy.
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Time from the first day of radiotherapy to the first determination of grade 2 or higher radiation dermatitis.
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From the start of radiotherapy to 4 weeks after completion of radiotherapy.
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Duration of grade ≥ 2 ARD between the two arms.
大体时间：From the start of radiotherapy to 4 weeks after completion of radiotherapy.
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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.
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From the start of radiotherapy to 4 weeks after completion of radiotherapy.
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Maximum dermatitis grade
大体时间：From the start of radiotherapy to 4 weeks after completion of radiotherapy.
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The maximum grade of RTOG skin toxicity between 0 and 4.
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From the start of radiotherapy to 4 weeks after completion of radiotherapy.
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Grade ≥3 radiation dermatitis incidence
大体时间：From the start of radiotherapy to 4 weeks after completion of radiotherapy.
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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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From the start of radiotherapy to 4 weeks after completion of radiotherapy.
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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总体健康状况与生活质量核心维度
大体时间：总评估期约为14至14.5周。
|
欧洲癌症研究与治疗组织生活质量核心问卷30（EORTC QLQ-C30）该工具是一项包含30个条目的患者报告结局（PRO）测量工具，旨在评估癌症患者健康相关生活质量的核心方面，包括5个功能量表（躯体功能、角色功能、认知功能、情绪功能、社会功能）、3个症状量表（疲劳、疼痛、恶心呕吐）、一个整体健康状况/生活质量量表，以及6个单项症状测量。
分数经过线性转换至0-100的范围。
对于功能量表和整体健康状况量表，分数越高表示功能水平或生活质量越好；对于症状量表/条目，分数越高表示症状负担越重。
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总评估期约为14至14.5周。
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头颈部癌症特异性症状
大体时间：总评估期约为14至14.5周。
|
EORTC QLQ-H&N35 是一种专门设计用于评估头颈癌患者疾病相关症状和治疗相关副作用的患者报告结局（PRO）工具。
它包含35个项目，分为七个多项目子量表（疼痛、吞咽、感官、言语、社交进食、社交接触和性功能）和十一个单项测量（如牙齿问题、张口困难、黏稠唾液、咳嗽等）。
所有子量表和单项得分均通过标准化评分算法线性转换为0-100分制。
分数解读：对于所有子量表和单项，分数越高代表症状越严重或症状负担越大。
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总评估期约为14至14.5周。
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Radiotherapy interruption rate
大体时间：Up to 8 weeks (from initiation to completion of radiotherapy)
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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.
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Up to 8 weeks (from initiation to completion of radiotherapy)
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Patient-reported skin symptoms from the Skindex-16
大体时间：From 1 week before 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.
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From 1 week before radiotherapy to 4 weeks after completion of radiotherapy.
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Skin microbiome composition and diversity
大体时间：Baseline and end of radiotherapy (approximately 8 weeks after radiotherapy initiation)
|
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)
|
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Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
大体时间：From 1 week before radiotherapy to 4 weeks after completion of radiotherapy.
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Common Terminology Criteria for Adverse Events (CTCAE) 5.0 version.
|
From 1 week before radiotherapy to 4 weeks after completion of radiotherapy.
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Xingchen Peng、study principal investigator
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年7月15日
初级完成 (估计的)
2026年12月30日
研究完成 (估计的)
2027年4月30日
研究注册日期
首次提交
2026年7月3日
首先提交符合 QC 标准的
2026年7月9日
首次发布 (实际的)
2026年7月15日
研究记录更新
最后更新发布 (实际的)
2026年7月15日
上次提交的符合 QC 标准的更新
2026年7月9日
最后验证
2026年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.