Radiation Dermatitis
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGROS-scavenging Nanoenzymes
ROS-scavenging nanoenzymes are applied to the treatment area, once daily during radiotherapy.
BEHAVIORALStandard of care
Standard of care
Sponsors
West China Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with a pathological diagnosis of non-metastatic head and neck malignant tumors; 2. Patients deemed suitable for high-dose radiotherapy, either as a primary treatment or as postoperative treatment following surgical resection.
Exclusion criteria
1. Eastern Cooperative Oncology Group performance status of \>2; 2. Pre-existing skin rash, ulceration or open wound in the treatment area; 3. Inflammatory or connective tissue disorder of the skin; 4. History of head and neck radiotherapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of grade 2 or higher radiation dermatitis | From the start of radiotherapy to 2 weeks after completion of radiotherapy. | Patients are assessed weekly for radiation dermatitis by an experienced radiation oncology nurse according to the Radiation Therapy Oncology Group (RTOG) criteria. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The maximum skin toxicity | From the start of radiotherapy to 2 weeks after completion of radiotherapy. | The maximum grade of RTOG skin toxicity between 0 and 4. |
Countries
China
Contacts
Primary ContactXingchen Peng, Prof.
Outcome results
None listed