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Набор скоро начнётся NCT07129525

Health Oriented Protocol for Epidermal Radiodermatitis

— Наблюдательное Head and Neck Cancer Pelvic Cancer Radiation Skin Injury Gynecologic Cancer

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: Radiation therapy.
Кому может быть актуально
Состояния в реестре: Head and Neck Cancer, Pelvic Cancer, Radiation Skin Injury, Gynecologic Cancer. Базовые параметры: от 18 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
Список центров уточняется — проверьте первичный протокол.
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

Health Oriented Protocol for Epidermal Radiodermatitis,A Prospective Observational Study

Обзор

Radiation therapy is a standard treatment for malignant tumors of the head and neck and pelvic regions, used alone or in combination with chemotherapy. While effective, it is often associated with adverse effects that can impact patient outcomes. Among the most frequent toxicities is radiation-induced dermatitis (RID), affecting up to 95% of patients. These skin reactions, ranging in severity, may compromise quality of life and lead to treatment interruptions.The severity of RID is influenced by both intrinsic and extrinsic factors. Intrinsic factors include age, sex, ethnicity, nutritional status, and comorbidities such as diabetes or systemic inflammation. Extrinsic factors include the radiation technique, total dose, treated volume, and presence of infections. These variables require close monitoring to reduce complications.Radiation damages the skin and underlying tissues, causing xerosis, pigmentation changes, loss of elasticity, fibrosis, and varying degrees of dermatitis. Effective prevention starts with patient education and skincare support throughout treatment to reduce incidence and severity.In Italy, head and neck cancers, though less common than other malignancies, present a significant clinical burden. Laryngeal cancer accounts for around 5,000 new cases annually. Oral cavity, pharyngeal, and thyroid tumors also have notable incidence and require complex treatments such as (chemo)radiotherapy, increasing the risk of RID.RID represents not only a clinical issue but also a psychological and functional challenge. Pain, emotional distress, and reduced autonomy are key aspects affecting patients' overall wellbeing. A multidimensional approach that integrates clinical care and psychosocial support is essential.This study aims to investigate the relationship between RID severity, pain, psychological distress, and functional autonomy during radiotherapy or chemoradiotherapy, identifying predictors of severe toxicity and guiding personalized supportive care.

Вмешательства

  • Лучевая терапия Radiation therapy
    Patients treated with radiotherapy will be evaluated within a period of five to seven weeks, during which time radiation-induced skin toxicities will be assessed.

Первичные конечные точки

  • Prevalence of radiation-induced dermatitis [Срок оценки: 5-7 weeks from treatment initiation]
  • Severity of radiation-induced dermatitis [Срок оценки: 5-7 weeks from treatment initiation]
Вторичные конечные точки (4)
  • Temporal evolution of dermatitis severity [Срок оценки: 5-7 weeks from treatment initiation]
  • Correlation between dermatitis severity and pain [Срок оценки: 5-7 weeks from treatment initiation]
  • Correlation between dermatitis severity and psychological distress [Срок оценки: 5-7 weeks from treatment initiation]
  • Correlation between dermatitis severity and functional autonomy [Срок оценки: 5-7 weeks from treatment initiation]

Критерии участия

Критерии включения

  • Patients aged ≥18 years
  • with head and neck or pelvic malignancies
  • undergoing either exclusive radiotherapy or concurrent chemoradiotherapy will be included, following signed informed consent.

Критерии исключения

  • Pediatric patients,
  • patients with malignancies outside the head and neck or pelvic regions,
  • patients who have not yet started or have already completed exclusive radiotherapy or concurrent chemoradiotherapy

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07129525 · 7545

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗