Menu
Recruiting NCT07064577

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

No phase Interventional Radiation Dermatitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ROS-scavenging Nanoenzymes, Standard of care.
Who it may be relevant to
Registry conditions: Radiation Dermatitis. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Detailed description

Radiotherapy often leads to various complications, with radiation dermatitis being the most common side effect observed in the majority of tumor patients undergoing treatment. This condition not only affects a patient's appearance but, in severe cases, may even require the interruption of treatment.

Currently, there is no standard treatment for radiation dermatitis. In this study, the investigators have designed novel ROS-scavenging nanoenzymes, offering a potential new approach for preventing and treating radiation dermatitis.

This clinical trial aims to evaluate the effectiveness of these novel ROS-scavenging nanoenzymes in preventing radiation dermatitis in patients with head and neck cancer.

Interventions

  • Drug ROS-scavenging Nanoenzymes
    ROS-scavenging nanoenzymes are applied to the treatment area, once daily during radiotherapy.
  • Behavioral Standard of care
    Standard of care

Primary outcome measures

  • The incidence of grade 2 or higher radiation dermatitis [Time frame: From the start of radiotherapy to 2 weeks after completion of radiotherapy.]
Secondary outcome measures (1)
  • The maximum skin toxicity [Time frame: From the start of radiotherapy to 2 weeks after completion of radiotherapy.]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

China · 1 center
  • West China Hospital, Sichuan University — Chengdu

Identifiers

NCT: NCT07064577 · 2024-134-1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗