Head and Neck CancerNCT06207708
Sarcopenia in Head and Neck Cancer Patients Treated with Curative Hadrontherapy
An observational study of Head and Neck Cancer, run by CNAO National Center of Oncological Hadrontherapy at 1 site in Italy.
Trial summary
The study focuses on the impact of sarcopenia on acute and late toxicities in head and neck tumor affected patients treated with particle therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- questionnaires QLQ-FA12, Mini Nutritional Assessment Short Form, Nutritional Risk Screening, diet questionnaire of frequency, ,body mass index measurement and blood biomarkers
- How many people
- 70 participants
- Where
- 1 siteItaly
- Study dates
- 18 Apr 2023to 31 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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: A sample of 70 patients of which 40% showing baseline sarcopenia will be recruited. The population is composed by head and neck patients treated with particle therapy, both carbon ions and protons.
Who may be able to join
- All HNC histologies and stages
- Histological and/or radiological diagnosis of head and neck tumors
- The patient is able to give consent
- Definitive/postoperative treatment with curative intent
- Age >18 years
- KPS> 80
Who cannot join
- Plurimetastiatic disease
- Palliative intent and re-irradiation treatments
- Known cases of any psychiatric and neurological diseases leading to disability (eg, manic disorder, schizophrenia etc..), which could impair compilation of questionnaires
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Baseline Sarcopenia in Determining Acute Toxicity for Head and Neck Cancer Patients Treated with Curative Hadrontherapy: a Prospective Monoinstitutional Study
The study focuses on the impact of sarcopenia on acute and late toxicities in head and neck tumor affected patients treated with particle therapy.
Read the detailed description
To evaluate in HNC patients treated with particle therapy the impact of SP (measured by low skeletal muscle mass at the C3 vertebral body) on toxicity profile assessed according to NCI's Common Terminology Criteria for Adverse Events CTCAE (version 5.0), defined as:
- Acute toxicity: within 3 months from the beginning of particle RT
- Late toxicity: more than 6 months after the end of particle RT. To investigate possible association between SP and nutritional
- Conditions
- Head and Neck Cancer
- Being tested
- questionnaires QLQ-FA12, Mini Nutritional Assessment Short Form, Nutritional Risk Screening, diet questionnaire of frequency, ,body mass index measurement, blood biomarkers
- Keywords
- particle therapy, head neck cancer, sarcopenia, hadrontherapy
- Medical subject headings
- Head and Neck Neoplasms, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaires QLQ-FA12, Mini Nutritional Assessment Short Form, Nutritional Risk Screening, diet questionnaire of frequency, ,body mass index measurementOther
the patient is administered with questionnaires focused on diet, fatigue, nutrition screening and on body mass index at the beginning and at the end pf particle therapy radiation treatment
blood biomarkersDiagnostic test
as per clinical routine, hemoglobin, lymphocytes, albumin and NLR will be collected
What is being measured
The primary outcome is the main question the study is designed to answer.
skeletal muscle strength mass (SMM)
measurement of sarcopenia to evaluate the development of the affection
Measured: before starting hadrontherapy treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start18 Apr 2023
- Primary completion31 Jan 2025
- Study completion31 Jan 2025
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
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- CNAO National Center of Oncological Hadrontherapy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rossana Ingargiola, MD, Principal investigator, CNAO National Center of Oncological Hadrontherapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06207708
- Sponsor's protocol ID
- CNAO 56 2023
- Status last verified
- Feb 2025
- First submitted
- 3 Jan 2024
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Baseline Sarcopenia in Determining Acute Toxicity for Head and Neck Cancer Patients Treated with Curative Hadrontherapy: a Prospective Monoinstitutional Study
- ClinicalTrials.gov ID
- NCT06207708
- Acronym / sponsor ID
- CNAO 56 2023
- Conditions
- Head and Neck Cancer
- Keywords
- particle therapy, head neck cancer, sarcopenia, hadrontherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- CNAO National Center of Oncological HadrontherapyUniversity, hospital or other
- Study start
- 18 Apr 2023 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 17 Jan 2024 (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 study focuses on the impact of sarcopenia on acute and late toxicities in head and neck tumor affected patients treated with particle therapy.
Detailed description
To evaluate in HNC patients treated with particle therapy the impact of SP (measured by low skeletal muscle mass at the C3 vertebral body) on toxicity profile assessed according to NCI's Common Terminology Criteria for Adverse Events CTCAE (version 5.0), defined as:
- Acute toxicity: within 3 months from the beginning of particle RT
- Late toxicity: more than 6 months after the end of particle RT. To investigate possible association between SP and nutritional
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
- A sample of 70 patients of which 40% showing baseline sarcopenia will be recruited. The population is composed by head and neck patients treated with particle therapy, both carbon ions and protons.
Key inclusion criteria (6 listed)
- All HNC histologies and stages
- Histological and/or radiological diagnosis of head and neck tumors
- The patient is able to give consent
- Definitive/postoperative treatment with curative intent
- Age >18 years
Key exclusion criteria (3 listed)
- Plurimetastiatic disease
- Palliative intent and re-irradiation treatments
- Known cases of any psychiatric and neurological diseases leading to disability (eg, manic disorder, schizophrenia etc..), which could impair compilation of questionnaires
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 QLQ-FA12, Mini Nutritional Assessment Short Form, Nutritional Risk Screening, diet questionnaire of frequency, ,body mass index measurementthe patient is administered with questionnaires focused on diet, fatigue, nutrition screening and on body mass index at the beginning and at the end pf particle therapy radiation treatment | Other | – |
| blood biomarkersas per clinical routine, hemoglobin, lymphocytes, albumin and NLR will be collected | Diagnostic test | – |
Primary outcome
skeletal muscle strength mass (SMM)
Time frame: before starting hadrontherapy treatment
measurement of sarcopenia to evaluate the development of the affection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Rossana Ingargiola, MD 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, 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 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: finished, as of the sponsor's last update on 13 Feb 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
skeletal muscle strength mass (SMM) (time frame: before starting hadrontherapy treatment). 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 13 Feb 2025.