Health-Oriented Protocol for Epidermal Radiodermatitis
Official title: Health Oriented Protocol for Epidermal Radiodermatitis,A Prospective Observational Study
Run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT07129525 · Data updated 2026-11-12
This study looks at how skin reactions from radiation therapy affect adults with head/neck or pelvic cancers and whether certain factors influence RID outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Drugs / interventions | chemotherapy, Radiation |
| Locations | 1 site (Roma, RM) |
| Status | Recruiting |
| Started | September 15, 2025 |
| Main results expected | March 31, 2027 |
| Study ends | March 31, 2027 |
| Registry record updated | October 14, 2026 |
| Trial ID | NCT07129525 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 years and older with head/neck or pelvic malignancies who are starting exclusive radiotherapy or concurrent chemoradiotherapy.
✕Probably not a fit
Patients not receiving radiotherapy or those with malignancies outside the specified regions may be less likely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational protocol aims to characterize radiation-induced dermatitis in adults undergoing radiotherapy for head and neck or pelvic cancers. It will collect data on intrinsic and extrinsic factors that may influence RID severity, such as patient demographics, comorbidities, radiation technique, dose, and infection status. The study involves patients receiving exclusive radiotherapy or concurrent chemoradiotherapy and follows them under standard care to identify patterns and potential predictors of RID. Results may help guide closer monitoring and supportive care to minimize skin toxicity during cancer treatment. The investigation is conducted at a single tertiary center in Rome, led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
Why it matters
Potential benefit: Understanding RID patterns could improve skin care strategies and reduce treatment interruptions for patients receiving radiotherapy.
How similar studies have gone: Previous work on RID has informed supportive care, but this observational approach aims to further characterize contributing factors in a real-world setting.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Fondazione Policlinico Universitario Gemelli IRCCS
Roma, Rm, Italy Recruiting
Study contacts
- Principal investigator: danilo pasini — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study coordinator: danilo pasini
- Email: danilo.pasini@policlinicogemelli.it
- Phone: +390630158372
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.