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

NCT ID: NCT07086638

Last Updated: 2025-09-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-25
• Study Completion Date: 2025-10-25

Brief Summary

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.

Detailed Description

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.

Conditions

Radiation Dermatitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Photo-responsive nanozyme

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.

Group Type: EXPERIMENTAL

Photo-responsive nanozyme

Intervention Type: 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.

Interventions

Photo-responsive nanozyme

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.

Intervention Type: DRUG

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 prussian blue;

4. Inflammatory or connective tissue disorder of the skin;

5. History of head and neck radiotherapy.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

West China Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xingchen Peng

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xingchen Peng

Role: PRINCIPAL_INVESTIGATOR

Sichuan University West China Hospital

Locations

Sichuan University West China Hospital

Chengdu, Sichuan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xingchen Peng

Role: CONTACT

pxx2014@163.com

+86 18980606753

Facility Contacts

Xingchen Peng

Role: primary

pxx2014@163.com

+86 18980606753

Other Identifiers

2024-134-2

Identifier Type: -

Identifier Source: org_study_id