ROS-Scavenging Nanozyme Combined With Thermotherapy Alleviate Radiation Dermatitis in Patients With Head and Neck Cancer
1 other identifier
interventional
5
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 15, 2025
CompletedFirst Posted
Study publicly available on registry
July 25, 2025
CompletedStudy Start
First participant enrolled
July 25, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 25, 2026
April 15, 2026
July 1, 2025
10 months
July 15, 2025
April 14, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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.
From the onset of Grade III dermatitis to two weeks after the completion of radiotherapy
Secondary Outcomes (1)
Bacterial load at the site of dermatitis
From the first administration of drug treatment through study completion, an average of 1 month.
Study Arms (1)
Photo-responsive nanozyme
EXPERIMENTALThe 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
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 Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sichuan University West China Hospital
Chengdu, Sichuan, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xingchen Peng
Sichuan University West China Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
July 15, 2025
First Posted
July 25, 2025
Study Start
July 25, 2025
Primary Completion (Estimated)
May 30, 2026
Study Completion (Estimated)
October 25, 2026
Last Updated
April 15, 2026
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share