Prussian blue nanozyme with near-infrared heat to heal severe radiation dermatitis after head and neck radiotherapy
ROS-Scavenging Nanozyme Combined With Near-Infrared Thermotherapy for the Amelioration of Grade III Radiation Dermatitis in Patients With Head and Neck Cancer
This will try a Prussian blue–based nanozyme together with near-infrared heat therapy to help heal Grade III radiation dermatitis in people receiving high‑dose radiotherapy for head and neck cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 5 (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 | NCT07086638 on ClinicalTrials.gov |
What this trial studies
Severe (Grade III) radiation dermatitis after head and neck radiotherapy can be hard to treat, and this approach combines a Prussian blue–based nanozyme with near‑infrared (NIR) thermotherapy to speed healing. Prussian blue is formulated as a photo‑responsive nanozyme intended to scavenge reactive oxygen species at the injury site and reduce inflammation. During treatment, the nanozyme is applied to the lesion and NIR light is used to trigger local thermal and therapeutic effects to promote tissue repair. The trial will enroll appropriate patients receiving high‑dose radiotherapy and monitor skin healing, safety, and symptom improvements.
Who should consider this trial
Good fit: Ideal candidates are people with non‑metastatic head and neck cancer who are receiving or planned for high‑dose radiotherapy and who develop Grade III radiation dermatitis without prior head and neck radiotherapy.
Not a fit: Patients with poor performance status (ECOG >2), pre‑existing rashes or open wounds in the treatment area, known allergy to trolamine or Prussian blue, inflammatory connective tissue skin disorders, or prior head and neck radiotherapy are unlikely to be eligible or to benefit.
Why it matters
Potential benefit: If successful, this approach could accelerate wound healing, reduce inflammation and pain, and improve quality of life for people with severe radiation dermatitis.
How similar studies have performed: Using Prussian blue as an ROS‑scavenging nanozyme combined with NIR thermotherapy is a novel clinical approach; similar nanozyme strategies have shown promise in preclinical studies but clinical evidence for this exact combination is limited.
Eligibility criteria
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 prussian blue; 4. Inflammatory or connective tissue disorder of the skin; 5. History of head and neck radiotherapy.
Where this trial is running
Chengdu, Sichuan
- Sichuan University West China Hospital — Chengdu, Sichuan, China (Recruiting)
Study contacts
- Principal investigator: Xingchen Peng — Sichuan University West China Hospital
- Study coordinator: Xingchen Peng
- Email: pxx2014@163.com
- Phone: +86 18980606753
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.