Head and Neck CancerHOPENCT07129525
Health Oriented Protocol for Epidermal Radiodermatitis
An observational study of Head and Neck Cancer and Pelvic Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Pelvic Cancer, Radiation Skin Injury
- What is being tested?
- Radiation therapy
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 15 Sep 2025to 31 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged ≥18 years with head and neck or pelvic malignancies undergoing either exclusive radiotherapy or concurrent chemoradiotherapy will be included
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario Gemelli IRCCS
Roma, RM, 00100
About this study
Official title: Health Oriented Protocol for Epidermal Radiodermatitis,A Prospective Observational Study
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
- Being tested
- Radiation therapy
- Medical subject headings
- Head and Neck Neoplasms, Pelvic Neoplasms, Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation therapyRadiation
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 5-7 weeks from treatment initiation
Secondary outcomes (4)
Temporal evolution of dermatitis severity
Change in toxicity grade of radiation-induced dermatitis across weekly assessments during radiotherapy or chemoradiotherapy, measured according to the CTCAE v5.0.
Unit of Measure: Change in CTCAE grade (0-5) over time
Measured: 5-7 weeks from treatment initiation
Correlation between dermatitis severity and pain
Correlation between dermatitis severity (CTCAE v5.0) and pain intensity (assessed with the Numeric Rating Scale, 0-10).
Unit of Measure: Correlation coefficient (r)
Measured: 5-7 weeks from treatment initiation
Correlation between dermatitis severity and psychological distress
Correlation between dermatitis severity (CTCAE v5.0) and psychological distress (assessed with the Distress Thermometer - DT).
Unit of Measure: Correlation coefficient (r)
Measured: 5-7 weeks from treatment initiation
Correlation between dermatitis severity and functional autonomy
Correlation between dermatitis severity (CTCAE v5.0) and functional autonomy (assessed with the Barthel Index).
Unit of Measure: Correlation coefficient (r)
Measured: 5-7 weeks from treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start15 Sep 2025
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- danilo pasini, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07129525
- Sponsor's protocol ID
- 7545
- Acronym
- HOPE
- Status last verified
- Sep 2026
- First submitted
- 11 Jul 2025
- Last updated
- 14 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Oriented Protocol for Epidermal Radiodermatitis,A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07129525
- Acronym / sponsor ID
- HOPE / 7545
- Conditions
- Head and Neck Cancer, Pelvic Cancer, Radiation Skin Injury, Gynecologic Cancer, Radiotherapy Side Effect
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 19 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged ≥18 years with head and neck or pelvic malignancies undergoing either exclusive radiotherapy or concurrent chemoradiotherapy will be included
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiation therapyPatients treated with radiotherapy will be evaluated within a period of five to seven weeks, during which time radiation-induced skin toxicities will be assessed. | Radiation | – |
Primary outcome
Prevalence of radiation-induced dermatitis
Time frame: 5-7 weeks from treatment initiation
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
Severity of radiation-induced dermatitis
Time frame: 5-7 weeks from treatment initiation
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)
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
danilo pasini principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Cancer and Pelvic Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact danilo pasini (+390630158372, danilo.pasini@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of radiation-induced dermatitis (time frame: 5-7 weeks from treatment initiation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.