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

West China Hospital5 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Radiation Dermatitis

Interventions

Photo-responsive nanozymeDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Sichuan University West China Hospital

Chengdu, Sichuan, China

RECRUITING

Outcomes

Primary Outcomes

The incidence of grade 3 radiation dermatitis

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

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

Secondary Outcomes

Bacterial load at the site of dermatitis

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

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

Central Contacts

Xingchen Peng

CONTACT

+86 18980606753 pxx2014@163.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.