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This is a prospective cohort study for the analysis of correlation between dosimetric parameters and RANV (Radiation Associated Nausea and Vomiting) in patients with head and neck cancer undergoing exclusive radiotherapy (RT).
The primary purpose of this study is to search for a potential correlation between dosimetry and physician- and patient-rated symptoms in patients treated with exclusive radiotherapy for head and neck cancer.
The use of Intensity Modulated Radiation Therapy (IMRT) has become increasingly common in clinical practice for the treatment of head and neck tumors. Despite the well-documented dosimetric advantages of IMRT, there has been a gradual recognition of toxicity profiles that are characteristic and distinct from those known in the era of 2D and 3D techniques, associated with the so-called "dose bath" typical of all intensity-modulated treatments. Among these, one of the main concerns is Radiation-Associated Nausea and Vomiting (RANV), the persistence and severity of which can significantly compromise the quality of life for patients.
Consequently, there has been a growing need to more thoroughly assess the clinical and dosimetric risk factors associated with the onset of RANV in this population. Although several authors have already investigated this aspect, most studies available to date consider cases where concurrent chemotherapy administration may affect the assessment of the outcomes of interest. Even when exclusively focusing on studies centered on IMRT (without concurrent chemotherapy), the generalization of results is at least partially affected by the fact that these are retrospective series with a relatively small population (23-130 patients).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exclusive Radiotherapy Treatment | Curative radiotherapy treatment using 3 Dimension (3D) conformal or Intensity Modulated Radiation Therapy (IMRT) techniques. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exclusive radiotherapy | Radiation | Curative radiotherapy treatment using 3D conformal or Intensity Modulated Radiation Therapy (IMRT) techniques. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of nausea (acute toxicity) using CTCAE V5.0 | Dose-response correlation between central nervous system (CNS) structures and substructures and nausea (Nausea will be scored using Common Terminology Criteria for Adverse Events- CTCAE- v 5.0 | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of nausea (acute toxicity) using M.D. Anderson Symptom Inventory (MDASI-SCORE) questionnaire | Dose-response correlation between central nervous system (CNS) structures and substructures and nausea evaluated by MDASI-CORE questionnaire | 3 months |
| Identification of the organs at risk most strongly correlated with the onset of nausea |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with head and neck neoplasms (early or locally advanced stage) treated solely with curative radiotherapy, having undergone contrast-enhanced magnetic resonance imaging (MRI), and for whom acute toxicity data are available.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stefania Volpe, MD | Contact | +3902574892418 | stefania.volpe@ieo.it |
| Name | Affiliation | Role |
|---|---|---|
| Stefania Volpe, MD | European Institute of Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona | Recruiting | Ancona | Italy |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Identification of the organs at risk most strongly correlated with the onset of nausea, both through the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (physician-rated outcome) and the MDASI-CORE questionnaire (patient-reported outcomes) |
| 3 months |
| Identification of dosimetric cutoffs for the onset of nausea | Identification of dosimetric cutoffs for the onset of nausea using Normal Tissue Complication Probability (NTCP) models | 3 months |
| Comparison of dosimetric analysis between 3D conformal, IMRT and proton therapy techniques | Dosimetric analysis comparing 3D conformal, IMRT, and proton therapy techniques, with a specific focus on the onset of nausea. Evaluation will be conducted using both the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 and the MDASI-CORE questionnaire | 3 months |
| Development of machine-learning predictive models for the onset of nausea | Development of machine-learning predictive models for the onset of nausea, incorporating clinical, dosimetric, and imaging parameters | 1 year |
| Ospedale "Mons. Dimiccoli" | Recruiting | Barletta | Italy |
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| Azienda Ospedaliera S.Pio | Recruiting | Benevento | Italy |
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| Ospedale MultiMedica | Recruiting | Castellanza | Italy |
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| IRCCS Ospedale Policlinico San Martino | Recruiting | Genova | Italy |
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| European Institute of Oncology | Recruiting | Milan | Italy |
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| IRCCS Ospedale San Raffaele | Recruiting | Milan | Italy |
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| Azienda Ospedaliero-Universitaria di Modena | Recruiting | Modena | Italy |
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| Azienda Ospedaliero Universitaria Ospedale Maggiore della Carità di Novara | Recruiting | Novara | Italy |
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| Fondazione IRCCS Policlinico San Matteo | Recruiting | Pavia | Italy |
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| Azienda Ospedaliera Complesso Ospedaliero San Giovanni - Addolorata | Recruiting | Roma | Italy |
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| Azienda Ospedaliero Universitaria Policlinico Umberto I | Recruiting | Roma | Italy |
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| Ospedale San Giovanni Calibita Fatebenefratelli Isola Tiberina | Recruiting | Roma | Italy |
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| I.R.C.C.S. MultiMedica - Sesto San Giovanni | Recruiting | Sesto San Giovanni | Italy |
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