Amino acid–derived antioxidant lipids to prevent and treat radiation skin damage in head and neck cancer
Official title: ROS-scavenging Amino Acid-derived Lipids for the Prevention and Treatment of Radiation Dermatitis in Patients With Head and Neck Cancer
Run by West China Hospital · NCT07081074 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | West China Hospital Academic / other |
| Drugs / interventions | Radiation |
| Locations | 1 site (Chengdu, Sichuan) |
| Status | Recruiting |
| Started | July 23, 2025 |
| Main results expected | May 23, 2026 |
| Study ends | December 23, 2026 |
| Registry record updated | April 15, 2026 |
| Trial ID | NCT07081074 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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).
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
West China Hospital, Sichuan University
Chengdu, Sichuan, China Recruiting
Study contacts
- Principal investigator: Xingchen Peng — Sichuan University West China Hospital
- Study coordinator: Xingchen Peng
- Email: pxx2014@163.com
- Phone: +8618980606753
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.