About this trial
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.
Eligibility criteria
Qualifiers
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 amino acid;
Inflammatory or connective tissue disorder of the skin;
Trial design
Treatments tested in this trial
- Amino acid-derived lipids
- standard of care