Health Oriented Protocol for Epidermal Radiodermatitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Radiation therapy.
- Who it may be relevant to
- Registry conditions: Head and Neck Cancer, Pelvic Cancer, Radiation Skin Injury, Gynecologic Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Health Oriented Protocol for Epidermal Radiodermatitis,A Prospective Observational Study
Overview
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.
Interventions
- Radiation 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.
Primary outcome measures
- Prevalence of radiation-induced dermatitis [Time frame: 5-7 weeks from treatment initiation]
- Severity of radiation-induced dermatitis [Time frame: 5-7 weeks from treatment initiation]
Secondary outcome measures (4)
- Temporal evolution of dermatitis severity [Time frame: 5-7 weeks from treatment initiation]
- Correlation between dermatitis severity and pain [Time frame: 5-7 weeks from treatment initiation]
- Correlation between dermatitis severity and psychological distress [Time frame: 5-7 weeks from treatment initiation]
- Correlation between dermatitis severity and functional autonomy [Time frame: 5-7 weeks from treatment initiation]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07129525 · 7545