ROS-scavenging nanoenzyme prevention for radiation dermatitis in head and neck cancer

Novel ROS-scavenging Nanoenzymes for the Treatment of Radiation Dermatitis in Patients With Head and Neck Cancer

This trial will try to see if giving novel ROS-scavenging nanoenzymes can prevent radiation-related skin damage in people receiving high-dose radiotherapy for head and neck cancer.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: West China Hospital (other)
• Drugs / interventions: radiation
• Locations: 1 site (Chengdu, Sichuan)
• Trial ID: NCT07064577 on ClinicalTrials.gov

What this trial studies

Radiotherapy for head and neck cancer commonly causes radiation dermatitis, which can affect appearance and sometimes require treatment breaks. This interventional study will give novel ROS-scavenging nanoenzymes alongside standard care and compare outcomes with standard care alone to see if dermatitis can be prevented. Key outcomes include the incidence and severity of skin reactions during radiotherapy and short-term follow-up. Eligible participants are adults with non-metastatic head and neck cancer planned for high-dose radiotherapy and without prior head and neck radiation or active skin disease in the treatment area.

Who should consider this trial

Good fit: Adults with non-metastatic head and neck malignancies who are scheduled for high-dose radiotherapy (primary or postoperative), have ECOG performance status ≤2, and have no prior head and neck radiotherapy or active skin lesions in the treatment area.

Not a fit: People with prior head and neck radiotherapy, preexisting skin ulcers or rashes in the treatment area, inflammatory or connective tissue skin disorders, poor performance status (ECOG >2), or metastatic disease are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the nanoenzymes could reduce how often and how severely radiation dermatitis occurs and help prevent interruptions to cancer treatment.

How similar studies have performed: Some topical and antioxidant approaches for radiation dermatitis have shown mixed or limited benefit, and ROS-scavenging nanoenzymes represent a novel approach with little prior clinical evidence.

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. Inflammatory or connective tissue disorder of the skin;
4. History of head and neck radiotherapy.

Where this trial is running

Chengdu, Sichuan

• West China Hospital, Sichuan University — Chengdu, Sichuan, China (RECRUITING)

Study contacts

• Principal investigator: Xingchen Peng, Prof. — Sichuan University West China Hospital
• Study coordinator: Xingchen Peng, Prof.

Conditions: Radiation Dermatitis