Clinical Trials in China / NCT07081074
Recruiting
Not applicable
ROS-scavenging Amino Acid-derived Lipids for the Prevention and Treatment of Radiation Dermatitis in Patients With Head and Neck Cancer
NCT07081074 · tracked via the Priya Life Science China tracker
Condition(s) studied
Radiation Dermatitis
Investigational drug(s) / intervention(s)
Amino acid-derived lipidsstandard of care
Amino acid-derived lipids: Amino acid-derived lipids are applied to the treatment area, once daily during radiotherapy.
standard of care: Standard of care
Study summary
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
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. Known allergy to trolamine or amino acid;
4. Inflammatory or connective tissue disorder of the skin;
5. History of head and neck radiotherapy.
Primary outcome measure(s)
- The incidence of 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.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| West China Hospital, Sichuan University | Chengdu | Sichuan | Recruiting |
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Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07081074 on ClinicalTrials.gov ↗ ← All trials in China