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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorWest China Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

5 Participants
are divided into 1 treatment group
Group A: Photo-responsive nanozymeExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
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

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.

Other outcomes

Sponsors and contacts

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