Novel ROS-scavenging Nanoenzymes for the Treatment of 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

There is no standard treatment for radiation dermatitis. In this study, the investigators have designed novel ROS-scavenging nanoenzymes and aim to evaluate their effectiveness in preventing radiation dermatitis in patients with head and neck cancer.

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;

Inflammatory or connective tissue disorder of the skin;

History of head and neck radiotherapy.

Trial design

Design model

Parallel

Treatments tested in this trial

  • ROS-scavenging Nanoenzymes

    Drug

    ROS-scavenging nanoenzymes are applied to the treatment area, once daily during radiotherapy.

  • Standard of care

    Behavioral

    Standard of care

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: ROS-scavenging NanoenzymesExperimental treatment 1 intervention
Group B: Standard of careActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

The incidence of grade 2 or higher 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 start of radiotherapy to 2 weeks after completion of radiotherapy.

Secondary outcomes

1

The maximum skin toxicity

The maximum grade of RTOG skin toxicity between 0 and 4.

Time frame
From the start of radiotherapy to 2 weeks after completion of radiotherapy.

Other outcomes

Sponsors and contacts

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