Health Oriented Protocol for Epidermal Radiodermatitis
A legfontosabb adatok
- Hol
- Roma (Olaszország)A helyszín megnézése
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- Életkor
- 18 éves vagy idősebb
- Nem
- Minden nem csatlakozhat
- A betegség stádiuma
- Daganat a fej-nyaki területen vagy a kismedencében
- Korábbi kezelés
- Jelenleg sugárkezelésben kell részesülnie, egyedül vagy kemoterápiával együtt. Aki még nem kezdte el, vagy már befejezte, nem vehet részt.
A részvétel fő kizáró okai
- Gyermekek
- A fej-nyaki területen vagy a kismedencén kívüli daganat
- Még el nem kezdett sugárkezelés vagy kemoradioterápia
- Már befejezett sugárkezelés vagy kemoradioterápia
Gépi kiolvasás: 2026. november 12.
Helyszínek itt: Olaszország
- Fondazione Policlinico Universitario Gemelli-IRCCSRoma, OlaszországContact: danilo pasiniRésztvevőt keres
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakA vizsgálat adatai
- Ki végzi
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Azonosító
- NCT07129525
- A regiszteradat frissítve
- 2026. október 14.
- Eredeti leírás
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.A teljes eredeti leírásKevesebb
Health Oriented Protocol for Epidermal Radiodermatitis,A Prospective Observational Study
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.
Bevonási feltételek: 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.
Kizáró feltételek: patients who have not yet started or have already completed exclusive radiotherapy or concurrent chemoradiotherapy; patients with malignancies outside the head and neck or pelvic regions,; Pediatric patients,.