Sichuan University West China Hospital
Chengdu, Sichuan, China
Location status: Recruiting
NCT Number: NCT07086638
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.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Not applicable
Chengdu, Sichuan, China
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
Contact information is provided by the study sponsor or research team.
West China Hospital
Other
ROS-Scavenging Nanozyme Combined With Near-Infrared Thermotherapy for the Amelioration of Grade III Radiation Dermatitis in Patients With Head and Neck Cancer
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