Clinical trial Recruiting at 1 site Observational Ages 18 and up

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 typeObservational
Ages18 Years and up
SexAll
Enrollment80 (estimated)
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS
Academic / other
Drugs / interventionschemotherapy, Radiation
Locations1 site (Roma, RM)
StatusRecruiting
StartedSeptember 15, 2025
Main results expectedMarch 31, 2027
Study endsMarch 31, 2027
Registry record updatedOctober 14, 2026
Trial IDNCT07129525 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.