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NCT Number: NCT07064577

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

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.

Recruiting

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Key information

Conditions

Radiation Dermatitis Dermatitis Radiation Injuries Radiodermatitis Skin Diseases Skin and Connective Tissue Diseases Wounds and Injuries

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

West China Hospital, Sichuan University

Chengdu, Sichuan, 610000, China

Location status: Recruiting

Location contact

Xingchen Peng, Phd, MD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ROS-scavenging Nanoenzymes

Drug

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

Standard of Care

Behavioral

Standard of care

Primary outcomes

  1. The incidence of grade 2 or higher radiation dermatitis

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

    Patients are assessed weekly for radiation dermatitis by an experienced radiation oncology nurse according to the Radiation Therapy Oncology Group (RTOG) criteria.

Secondary outcomes

  1. The maximum skin toxicity

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Xingchen Peng, Prof.

CONTACT

[email protected]

+86 18980606753

Sponsors and collaborators

Lead sponsor

West China Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 14, 2025
Registry last updated
Aug 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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