Clinical trial Recruiting at 1 site Interventional Ages 18 to 80

Prussian blue nanozyme with near-infrared heat to heal severe radiation dermatitis after head and neck radiotherapy

Official title: ROS-Scavenging Nanozyme Combined With Near-Infrared Thermotherapy for the Amelioration of Grade III Radiation Dermatitis in Patients With Head and Neck Cancer

Run by West China Hospital · NCT07086638 · Data updated 2026-11-12

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.

More Radiation Dermatitis trials

Quick facts

Study typeInterventional
Ages18 Years to 80 Years
SexAll
Enrollment5 (estimated)
SponsorWest China Hospital
Academic / other
Drugs / interventionsradiation
Locations1 site (Chengdu, Sichuan)
StatusRecruiting
StartedJuly 25, 2025
Main results expectedMay 30, 2026
Study endsOctober 25, 2026
Registry record updatedApril 15, 2026
Trial IDNCT07086638 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

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 prussian blue;
4. Inflammatory or connective tissue disorder of the skin;
5. History of head and neck radiotherapy.

Where it's running

  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.