Radiation dermatitis is a common complication in head and neck squamous cell carcinoma patients receiving radiotherapy. This study proposes an ROS-scavenging amino acid-based nanolipid to prevent oxidative skin damage. A multicenter randomized trial will evaluate its safety and efficacy in reducing dermatitis severity and improving treatment continuity.
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.
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 amino acid;
Inflammatory or connective tissue disorder of the skin;
Parallel
Amino acid-derived lipids
DrugAmino acid-derived lipids are applied to the treatment area, once daily during radiotherapy.
standard of care
BehavioralStandard of care
The incidence of radiation dermatitis
Patients are assessed weekly for radiation dermatitis by an experienced radiation oncology nurse according to the Radiation Therapy Oncology Group (RTOG) criteria.
The maximum skin toxicity
The maximum grade of RTOG skin toxicity between 0 and 4.
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