Radiation Dermatitis
Conditions
Brief 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.
Detailed description
Radiation dermatitis represents one of the most frequent complications in patients with head and neck squamous cell carcinoma (including nasopharyngeal carcinoma) undergoing radiotherapy, often leading to treatment interruption and compromised therapeutic outcomes. To address the limitations of current preventive strategies, this project proposes a novel amino acid-based lipid formulation designed to scavenge reactive oxygen species (ROS). Leveraging FDA-approved natural amino acids and engineered into a unique nanoliposomal structure, this formulation enables efficient delivery of antioxidative agents, effectively neutralizing excess ROS generated during radiotherapy while activating endogenous antioxidant signaling pathways, thereby mitigating oxidative damage to dermal cells. A multicenter randomized controlled clinical trial will be conducted to systematically evaluate the efficacy and safety of this intervention in reducing the incidence and severity of radiation dermatitis. This study will provide a clinically viable and safe prophylactic strategy, enhancing patients' quality of life and ensuring uninterrupted radiotherapy, with significant translational and societal implications.
Interventions
DRUGAmino acid-derived lipids
Amino acid-derived lipids are applied to the treatment area, once daily during radiotherapy.
BEHAVIORALstandard of care
Standard of care
Sponsors
West China Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The maximum skin toxicity | From the start of radiotherapy to 2 weeks after completion of radiotherapy. | The maximum grade of RTOG skin toxicity between 0 and 4. |
Countries
China
Contacts
CONTACTXingchen Peng
PRINCIPAL_INVESTIGATORXingchen Peng
Sichuan University West China Hospital
Outcome results
None listed