About this trial
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.
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;
Inflammatory or connective tissue disorder of the skin;
History of head and neck radiotherapy.
Trial design
Parallel
Treatments tested in this trial
ROS-scavenging Nanoenzymes
DrugROS-scavenging nanoenzymes are applied to the treatment area, once daily during radiotherapy.
Standard of care
BehavioralStandard of care
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
The maximum skin toxicity
The maximum grade of RTOG skin toxicity between 0 and 4.
Sponsors and contacts
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