About this trial
Severe radiation dermatitis remains a challenging complication in head and neck cancer with limited treatment options; this study aims to evaluate a novel Prussian blue-based nanozyme combined with near-infrared thermotherapy to promote effective healing of Grade III lesions.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with a pathological diagnosis of non-metastatic head and neck malignant tumors;
Patients deemed suitable for high-dose radiotherapy, either as a primary treatment or as postoperative treatment following surgical resection.
Disqualifiers
Eastern Cooperative Oncology Group performance status of >2;
Pre-existing skin rash, ulceration or open wound in the treatment area;
Known allergy to trolamine or prussian blue;
Inflammatory or connective tissue disorder of the skin;
Trial design
Single group
Treatments tested in this trial
Photo-responsive nanozyme
DrugThe nanozyme scavenges ROS at the site of dermatitis and simultaneously responds to NIR light to generate mild heat, thereby promoting the healing of radiation-induced skin injury.
Treatment groups
Trial outcomes
Primary outcomes
The incidence of grade 3 radiation dermatitis
Patients are assessed weekly for radiation dermatitis by an experienced radiation oncology nurse according to the Radiation Therapy Oncology Group (RTOG) criteria.
Secondary outcomes
Bacterial load at the site of dermatitis
Experienced radiation oncology nurses took samples from the patients' radiation dermatitis areas, and professional medical laboratory nurses performed bacterial load analysis.
Sponsors and contacts
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