Идёт набор NCT07086638

ROS-Scavenging Nanozyme Combined With Thermotherapy Alleviate Radiation Dermatitis in Patients With Head and Neck Cancer

Без фазы С лечением Radiation Dermatitis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Photo-responsive nanozyme.
Кому может быть актуально: Состояния в реестре: Radiation Dermatitis. Базовые параметры: 18 лет — 80 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Китай
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

ROS-Scavenging Nanozyme Combined With Near-Infrared Thermotherapy for the Amelioration of Grade III Radiation Dermatitis in Patients With Head and Neck Cancer

Обзор

Severe radiation dermatitis remains a challenging complication in head and neck cancer with limited treatment options; this study aims to evaluate a novel Prussian blue-based nanozyme combined with near-infrared thermotherapy to promote effective healing of Grade III lesions.

Подробное описание

Radiation dermatitis is a common and challenging complication for patients undergoing radiotherapy, especially those with head and neck cancer. Currently, there are limited effective clinical treatments available for managing severe (Grade III) radiation-induced skin damage.

This study aims to explore a novel and safe treatment strategy for alleviating Grade III radiation dermatitis. The investigators use Prussian blue, an FDA-approved compound known for its reactive oxygen species (ROS) scavenging ability, formulated into a nanozyme that targets oxidative stress at the injury site. When combined with near-infrared (NIR) thermotherapy, this approach promotes faster skin repair and reduces inflammation.

This study's goal is to provide an effective and patient-friendly therapeutic option that accelerates healing and improves quality of life for individuals suffering from severe radiation dermatitis.

Вмешательства

Препарат Photo-responsive nanozyme
The nanozyme scavenges ROS at the site of dermatitis and simultaneously responds to NIR light to generate mild heat, thereby promoting the healing of radiation-induced skin injury.

Первичные конечные точки

The incidence of grade 3 radiation dermatitis [Срок оценки: From the onset of Grade III dermatitis to two weeks after the completion of radiotherapy]

Вторичные конечные точки (1)

Bacterial load at the site of dermatitis [Срок оценки: From the first administration of drug treatment through study completion, an average of 1 month.]

Критерии участия

Критерии включения

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.