ROS-scavenging Amino Acid-derived Lipids for the Prevention and Treatment of Radiation Dermatitis in Patients With Head and Neck Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Amino acid-derived lipids, standard of care.
- Who it may be relevant to
- Registry conditions: Radiation Dermatitis. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Drug Amino acid-derived lipids
Amino acid-derived lipids are applied to the treatment area, once daily during radiotherapy. - Behavioral standard of care
Standard of care
Primary outcome measures
- The incidence of radiation dermatitis [Time frame: From the start of radiotherapy to 2 weeks after completion of radiotherapy.]
Secondary outcome measures (1)
- The maximum skin toxicity [Time frame: From the start of radiotherapy to 2 weeks after completion of radiotherapy.]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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;
- History of head and neck radiotherapy.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
China · 1 center
- West China Hospital, Sichuan University — Chengdu
Identifiers
NCT: NCT07081074 · 2024-134-3