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NCT Number: NCT07086638

ROS-Scavenging Nanozyme Combined With Thermotherapy Alleviate Radiation Dermatitis in Patients With Head and Neck Cancer

Severe radiation dermatitis remains a challenging complication in head and neck cancer with limited treatment options; this study aims to evaluate a novel Prussian blue-based nanozyme combined with near-infrared thermotherapy to promote effective healing of Grade III lesions.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sichuan University West China Hospital

Chengdu, Sichuan, China

Location status: Recruiting

Location contact

Xingchen Peng

CONTACT

[email protected]

+86 18980606753

About this study

Radiation dermatitis is a common and challenging complication for patients undergoing radiotherapy, especially those with head and neck cancer. Currently, there are limited effective clinical treatments available for managing severe (Grade III) radiation-induced skin damage.

This study aims to explore a novel and safe treatment strategy for alleviating Grade III radiation dermatitis. The investigators use Prussian blue, an FDA-approved compound known for its reactive oxygen species (ROS) scavenging ability, formulated into a nanozyme that targets oxidative stress at the injury site. When combined with near-infrared (NIR) thermotherapy, this approach promotes faster skin repair and reduces inflammation.

This study's goal is to provide an effective and patient-friendly therapeutic option that accelerates healing and improves quality of life for individuals suffering from severe radiation dermatitis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with a pathological diagnosis of non-metastatic head and neck malignant tumors;
  • Patients deemed suitable for high-dose radiotherapy, either as a primary treatment or as postoperative treatment following surgical resection.

Exclusion criteria

  • Eastern Cooperative Oncology Group performance status of >2;
  • Pre-existing skin rash, ulceration or open wound in the treatment area;
  • Known allergy to trolamine or prussian blue;
  • Inflammatory or connective tissue disorder of the skin;
  • History of head and neck radiotherapy.

Treatment and study plan

Photo-responsive nanozyme

Drug

The nanozyme scavenges ROS at the site of dermatitis and simultaneously responds to NIR light to generate mild heat, thereby promoting the healing of radiation-induced skin injury.

Primary outcomes

  1. The incidence of grade 3 radiation dermatitis

    Time frame: From the onset of Grade III dermatitis to two weeks after the completion of radiotherapy

    Patients are assessed weekly for radiation dermatitis by an experienced radiation oncology nurse according to the Radiation Therapy Oncology Group (RTOG) criteria.

Secondary outcomes

  1. Bacterial load at the site of dermatitis

    Time frame: From the first administration of drug treatment through study completion, an average of 1 month.

    Experienced radiation oncology nurses took samples from the patients' radiation dermatitis areas, and professional medical laboratory nurses performed bacterial load analysis.

Study contacts

Contact information is provided by the study sponsor or research team.

Xingchen Peng

CONTACT

[email protected]

+86 18980606753

Sponsors and collaborators

Lead sponsor

West China Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 25, 2025
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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