Head and Neck CancerHadroQoLNCT05947149
HRQoL in Patients With Solid Tumors Treated With Hadrontherapy
An observational study of Head and Neck Cancer and Skull Base--Cancer, run by CNAO National Center of Oncological Hadrontherapy at 1 site in Italy.
Trial summary
The Quality of Life of patients treated with hadrontherapy is still limited. Two cohorts are established, they will be receiving specific standardized questionnaires to be evalutaed in their results. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Skull Base--Cancer, Brain Cancer
- What is being tested?
- questionnaires administration
- How many people
- 180 participants
- Where
- 1 siteItaly
- Study dates
- 27 Mar 2023to 26 Sep 2025
- 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: The patients from cohort A will be selected and invited to participate in the study when evaluated for standard of care follow-up which is taking place in telemedicine modality through a digital meeting organized by the staff. Patients from Cohort B with indication of hadrontherapy in radical setting will be consecutively enrolled at baseline (during CT simulation procedure or at the first session of RT).
Who may be able to join
- Patients with at least a follow up of 5 years with head and neck, skull base and brain tumors and no evidence of progressive disease.
- The patient is able to give consent
- Histological and/or radiological diagnosis of head and neck tumors
- Patients candidate for curative intent hadrontherapy
- Patients ≥ 18 years of age
- The patient is able to give consent
Who cannot join
- Re-irradiation.
- Second tumor.
- Known cases of any psychiatric and neurological diseases leading to disability (eg, manic disorder, schizophrenia etc..), which could impair compilation of questionnaires or affect quality of life.
- Cohort B:
- Re-irradiation.
- Second tumor
- Known cases of any psychiatric and neurological diseases leading to disability (eg, manic disorder, schizophrenia etc..), which could impair compilation of questionnaires or affect quality of life
- Presence of diffused metastasis
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
CNAO
Pavia, Pv, 27100
Cristina Bono, MSc, 0382078613, cristina.bono@cnao.it
About this study
Official title: Health Related Quality of Life (HRQoL) in Patients With Solid Tumors Treated With Hadrontherapy (HadroQoL).
The Quality of Life of patients treated with hadrontherapy is still limited. Two cohorts are established, they will be receiving specific standardized questionnaires to be evalutaed in their results.
Read the detailed description
Since 2011, CNAO has been treating patients suffering from solid tumors with particle therapy (both protons and carbon ions). Hadrontherapy improves outcome of radioresistant tumors which normally do not benefit from conventional radiotherapy. The treated population is highly heterogenous in term of tumor site, histotype, treatment fields and doses however its common anatomical origin justifies a unified approach in evaluating a QoL in this setting. QoL of patients suffering from these tumors have been poorly investigated and there are still few studies on patient reported outcomes (PROs) and QoL following hadrontherapy. In this context, therefore, there is a need to generate data by designing distinct cohort studies, conceived within a single protocol, that will gather quality of life data by means of standardized questionnaires of patients along their oncological history. Thanks to this protocol design, the investigator will be facilitated, in the future, in adding new cohorts pending a study protocol amendment and ethical approval.
- Conditions
- Head and Neck Cancer, Skull Base--Cancer, Brain Cancer
- Being tested
- questionnaires administration
- Keywords
- cancer free survisorship, hadrontherapy, quality of life
- Medical subject headings
- Head and Neck Neoplasms, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaires administrationOther
Enrolled people will be requested to fill in questionnaires. Cohort A affected by head and neck cancer: SF-12, EORTC QLQ-C30, EORTC QLQ-H\&N43, HADS, Brief COPE, BRCS.
Cohort A affected by skull base/brain cancer: SF-12, EORTC QLQ-BN20, HADS, Brief COPE, BRCS.
Cohort B will receive: EORTC QLQ-C30, BRCS, PROFFIT, SF-12, EORTC QLQ-H\&N43.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A Survivors | about 80 patients with at least a 5 year follow up with head and neck, skull base and brain tumors and no evidence of progressive disease. Receives: Other: questionnaires administration | |
| Cohort B | 100 patients with histological and/or radiological diagnosis of head and neck tumors enrolled at baseline Receives: Other: questionnaires administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
investigate relation between quality of life and several socio- psycho- variables
quality of life in subjects treated with curative hadrontherapy investigated by global score according to Short-form-12-health-survey-questionnaire (SF-12) and compared to healthy population
Measured: 5 years follow uo after hadrontherapy
Secondary outcomes (1)
quality of life related also to psychological variables, socio-cognitive factors, resilience
quality of life in subjects treated with curative hadrontherapy investigated by global score according to EORTC QLQ-C30
Measured: before treatment and after 1 year from treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2023
- Study start27 Mar 2023
- Primary completion26 Sep 2025 (estimated)
- Study completion26 Sep 2025 (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
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CNAO National Center of Oncological Hadrontherapy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anna Maria Camarda, Principal investigator, CNAO National Center of Oncological Hadrontherapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05947149
- Sponsor's protocol ID
- CNAO OSS 52 2022
- Acronym
- HadroQoL
- Status last verified
- Aug 2025
- First submitted
- 7 Jul 2023
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Related Quality of Life (HRQoL) in Patients With Solid Tumors Treated With Hadrontherapy (HadroQoL).
- ClinicalTrials.gov ID
- NCT05947149
- Acronym / sponsor ID
- HadroQoL / CNAO OSS 52 2022
- Conditions
- Head and Neck Cancer, Skull Base--Cancer, Brain Cancer
- Keywords
- cancer free survisorship, hadrontherapy, quality of life
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- CNAO National Center of Oncological HadrontherapyUniversity, hospital or other
- Study start
- 27 Mar 2023 (actual)
- Primary completion
- 26 Sep 2025 (estimated)
- Study completion
- 26 Sep 2025 (estimated)
- First posted
- 17 Jul 2023 (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.
The Quality of Life of patients treated with hadrontherapy is still limited. Two cohorts are established, they will be receiving specific standardized questionnaires to be evalutaed in their results.
Detailed description
Since 2011, CNAO has been treating patients suffering from solid tumors with particle therapy (both protons and carbon ions). Hadrontherapy improves outcome of radioresistant tumors which normally do not benefit from conventional radiotherapy. The treated population is highly heterogenous in term of tumor site, histotype, treatment fields and doses however its common anatomical origin justifies a unified approach in evaluating a QoL in this setting. QoL of patients suffering from these tumors have been poorly investigated and there are still few studies on patient reported outcomes (PROs) and QoL following hadrontherapy. In this context, therefore, there is a need to generate data by designing distinct cohort studies, conceived within a single protocol, that will gather quality of life data by means of standardized questionnaires of patients along their oncological history. Thanks to this protocol design, the investigator will be facilitated, in the future, in adding new cohorts pending a study protocol amendment and ethical approval.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A Survivors | – | Other: questionnaires administrationabout 80 patients with at least a 5 year follow up with head and neck, skull base and brain tumors and no evidence of progressive disease. |
| Cohort B | – | Other: questionnaires administration100 patients with histological and/or radiological diagnosis of head and neck tumors enrolled at baseline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients from cohort A will be selected and invited to participate in the study when evaluated for standard of care follow-up which is taking place in telemedicine modality through a digital meeting organized by the staff. Patients from Cohort B with indication of hadrontherapy in radical setting will be consecutively enrolled at baseline (during CT simulation procedure or at the first session of RT).
Key inclusion criteria (6 listed)
- Patients with at least a follow up of 5 years with head and neck, skull base and brain tumors and no evidence of progressive disease.
- The patient is able to give consent
- Histological and/or radiological diagnosis of head and neck tumors
- Patients candidate for curative intent hadrontherapy
- Patients ≥ 18 years of age
Key exclusion criteria (8 listed)
- Re-irradiation.
- Second tumor.
- Known cases of any psychiatric and neurological diseases leading to disability (eg, manic disorder, schizophrenia etc..), which could impair compilation of questionnaires or affect quality of life.
- Re-irradiation.
- Second tumor
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 |
|---|---|---|
| questionnaires administrationEnrolled people will be requested to fill in questionnaires. Cohort A affected by head and neck cancer: SF-12, EORTC QLQ-C30, EORTC QLQ-H\&N43, HADS, Brief COPE, BRCS. Cohort A affected by skull base/brain cancer: SF-12, EORTC QLQ-BN20, HADS, Brief COPE, BRCS. Cohort B will receive: EORTC QLQ-C30, BRCS, PROFFIT, SF-12, EORTC QLQ-H\&N43. | Other | Cohort A Survivors, Cohort B |
Primary outcome
investigate relation between quality of life and several socio- psycho- variables
Time frame: 5 years follow uo after hadrontherapy
quality of life in subjects treated with curative hadrontherapy investigated by global score according to Short-form-12-health-survey-questionnaire (SF-12) and compared to healthy population
1 secondary outcome
quality of life related also to psychological variables, socio-cognitive factors, resilience
Time frame: before treatment and after 1 year from treatment completion
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 6 Aug 2025.
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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.
Anna Maria Camarda principal investigator
CNAO National Center of Oncological Hadrontherapy
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 Skull Base--Cancer, run by CNAO National Center of Oncological Hadrontherapy 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 6 inclusion and 8 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 6 Aug 2025. 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 Anna Maria Camarda (+390382078501, camarda@cnao.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
investigate relation between quality of life and several socio- psycho- variables (time frame: 5 years follow uo after hadrontherapy). 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 6 Aug 2025.