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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-15

Study Completion Date

2025-10-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Radiation Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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ROS-scavenging Nanoenzymes

Group Type EXPERIMENTAL

ROS-scavenging Nanoenzymes

Intervention Type DRUG

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

Standard of care

Group Type ACTIVE_COMPARATOR

Standard of care

Intervention Type BEHAVIORAL

Standard of care

Interventions

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ROS-scavenging Nanoenzymes

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

Intervention Type DRUG

Standard of care

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No