Clinical trial · Observational
Health Oriented Protocol for Epidermal Radiodermatitis
Health Oriented Protocol for Epidermal Radiodermatitis,A Prospective Observational Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gynecologic Cancer | Malignant Female Reproductive System Neoplasm | ALIAS | 0.90 |
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Pelvic Cancer | Malignant Pelvic Neoplasm | ALIAS | 0.90 |
| Radiation Skin Injury | — | UNRESOLVED | — |
| Radiotherapy Side Effect | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Prevalence of radiation-induced dermatitis
- timeFrame
- 5-7 weeks from treatment initiation
- description
- 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
- measure
- Severity of radiation-induced dermatitis
- timeFrame
- 5-7 weeks from treatment initiation
- description
- 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)
Secondary outcomes (4)
- measure
- Temporal evolution of dermatitis severity
- timeFrame
- 5-7 weeks from treatment initiation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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
References
Publications (0)
Data not yet available