ROS-scavenging Amino Acid-derived Lipids for the Prevention and Treatment of Radiation Dermatitis in Patients With Head and Neck Cancer

Sichuan University

Status: Enrolling

Conditions: Radiation Dermatitis

Treatments: Behavioral: standard of care; Drug: Amino acid-derived lipids

Study type: Interventional

Funder types: Other

Identifiers

NCT07081074

2024-134-3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Amino acid-derived lipids

Experimental group

Treatment:

Drug: Amino acid-derived lipids

standard of care

Active Comparator group

Treatment:

Behavioral: standard of care