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临床试验/NCT07129525
NCT07129525尚未招募不适用

Health Oriented Protocol for Epidermal Radiodermatitis,A Prospective Observational Study

Fondazione Policlinico Universitario Agostino Gemelli IRCCS0 个研究点目标入组 80 人开始时间: 2025年9月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
80
主要终点
Prevalence of radiation-induced dermatitis

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

结局指标

主要结局

Prevalence of radiation-induced dermatitis

时间窗: 5-7 weeks from treatment initiation

Proportion of patients undergoing radiotherapy or chemoradiotherapy for head and neck or pelvic cancers who develop radiation-induced dermatitis, assessed according to the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Unit of Measure: % of patients with grade ≥1 dermatitis

Severity of radiation-induced dermatitis

时间窗: 5-7 weeks from treatment initiation

Maximum grade of radiation-induced dermatitis in patients undergoing radiotherapy or chemoradiotherapy for head and neck or pelvic cancers, assessed according to the CTCAE v5.0. Unit of Measure: CTCAE grade (0-5)

次要结局

  • Temporal evolution of dermatitis severity(5-7 weeks from treatment initiation)
  • Correlation between dermatitis severity and pain(5-7 weeks from treatment initiation)
  • Correlation between dermatitis severity and psychological distress(5-7 weeks from treatment initiation)
  • Correlation between dermatitis severity and functional autonomy(5-7 weeks from treatment initiation)

研究者

申办方类型
Other
责任方
Sponsor

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