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There is no standard treatment for radiation dermatitis. In this study, the investigators have designed novel ROS-scavenging nanoenzymes and aim to evaluate their effectiveness in preventing radiation dermatitis in patients with head and neck cancer.
Radiotherapy often leads to various complications, with radiation dermatitis being the most common side effect observed in the majority of tumor patients undergoing treatment. This condition not only affects a patient's appearance but, in severe cases, may even require the interruption of treatment.
Currently, there is no standard treatment for radiation dermatitis. In this study, the investigators have designed novel ROS-scavenging nanoenzymes, offering a potential new approach for preventing and treating radiation dermatitis.
This clinical trial aims to evaluate the effectiveness of these novel ROS-scavenging nanoenzymes in preventing radiation dermatitis in patients with head and neck cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ROS-scavenging Nanoenzymes | Experimental |
| |
| Standard of care | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ROS-scavenging Nanoenzymes | Drug | ROS-scavenging nanoenzymes are applied to the treatment area, once daily during radiotherapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of grade 2 or higher radiation dermatitis | Patients are assessed weekly for radiation dermatitis by an experienced radiation oncology nurse according to the Radiation Therapy Oncology Group (RTOG) criteria. | From the start of radiotherapy to 2 weeks after completion of radiotherapy. |
| Measure | Description | Time Frame |
|---|---|---|
| The maximum skin toxicity | The maximum grade of RTOG skin toxicity between 0 and 4. | From the start of radiotherapy to 2 weeks after completion of radiotherapy. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xingchen Peng, Prof. | Contact | +86 18980606753 | pxx2014@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xingchen Peng, Prof. | Sichuan University West China Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital, Sichuan University | Recruiting | Chengdu | Sichuan | 610000 | China |
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| ID | Term |
|---|---|
| D011855 | Radiodermatitis |
| ID | Term |
|---|---|
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D011832 | Radiation Injuries |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard of care | Behavioral | Standard of care |
|
| D014947 |
| Wounds and Injuries |