Amino acid–derived antioxidant lipids to prevent and treat radiation skin damage in head and neck cancer

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

This trial will try a new amino acid–based lipid treatment that soaks up harmful reactive oxygen species to prevent or lessen radiation dermatitis in people receiving high‑dose radiotherapy for head and neck cancer.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: West China Hospital (Academic / other)
• Drugs / interventions: Radiation
• Locations: 1 site (Chengdu, Sichuan)
• Trial ID: NCT07081074 on ClinicalTrials.gov

What this trial studies

Radiation dermatitis is a frequent complication of high‑dose radiotherapy for head and neck cancers and can lead to treatment interruptions. This multicenter randomized controlled trial will test an amino acid–derived nanoliposomal lipid designed to scavenge reactive oxygen species and protect skin during radiotherapy. The formulation leverages natural amino acids assembled into nanoliposomes to neutralize ROS and activate endogenous antioxidant pathways, with the goal of reducing skin damage. Participants will be randomized to receive the lipid intervention plus standard care or standard care alone, and outcomes will include dermatitis severity, safety, and continuity of radiotherapy.

Who should consider this trial

Good fit: Ideal candidates are people with non‑metastatic head and neck malignancies who are scheduled to receive high‑dose radiotherapy as primary or postoperative treatment and who have adequate performance status (ECOG ≤2).

Not a fit: Patients with pre‑existing skin rash, ulcers or open wounds in the treatment area, inflammatory or connective tissue skin disorders, known allergy to trolamine or amino acids, or prior head and neck radiotherapy are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, the treatment could reduce the severity of radiation dermatitis, decrease therapy interruptions, and improve quality of life during head and neck radiotherapy.

How similar studies have performed: Topical antioxidants have been tried for radiation dermatitis, but amino acid–derived ROS‑scavenging nanolipids represent a largely novel approach with limited prior clinical data.

Eligibility criteria

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.

Where this trial is running

Chengdu, Sichuan

• West China Hospital, Sichuan University — Chengdu, Sichuan, China (Recruiting)

Study contacts

• Principal investigator: Xingchen Peng — Sichuan University West China Hospital
• Study coordinator: Xingchen Peng

Conditions Radiation Dermatitis