Health Oriented Protocol for Epidermal Radiodermatitis

NCT07129525 | Not Yet Recruiting

• 1 other identifier: 7545
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Head and Neck Cancer; Pelvic Cancer; Radiation Skin Injury; Gynecologic Cancer; Radiotherapy Side Effect

Outcome Measures

Primary Outcomes (2)

• Prevalence of radiation-induced dermatitis

  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

  5-7 weeks from treatment initiation

• Severity of radiation-induced dermatitis

  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)

  5-7 weeks from treatment initiation

Secondary Outcomes (4)

• 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

Interventions

Radiation therapy RADIATION

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients aged ≥18 years with head and neck or pelvic malignancies undergoing either exclusive radiotherapy or concurrent chemoradiotherapy will be included

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

MeSH Terms

Conditions

Head and Neck Neoplasms; Pelvic Neoplasms; Radiation Injuries

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• danilo pasini

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

danilo pasini

CONTACT

+390630158372; danilo.pasini@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2025
• First Posted: August 19, 2025
• Study Start: September 1, 2025
• Primary Completion: March 31, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: August 19, 2025

Record last verified: 2025-07