Clinical trial NCT06341985: DOsimetry and Radiation Induced NAusea in Head and Neck Cancers
Official title: Prospective Multicenter 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)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Head and Neck Cancer
Keywords: Head and Neck Cancer
Exclusive Radiotherapy
Lead sponsor: European Institute of Oncology
Sponsor class: OTHER
First posted: 2024-04-02
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* Patients aged ≥ 18 years
* Diagnosis of primary head and neck neoplasm in the following subsites: oropharynx, nasopharynx, oral cavity, paranasal sinuses, salivary glands, and neoplasms with an unknown primary focus.
* Curative radiotherapeutic treatment with photons or protons using 3D conformal or Intensity Modulated Radiation Therapy (IMRT), Volumetric Modulated Arc Therapy (VMAT), Tomotherapy; both photon and proton treatments are allowed.
* Ability to prospectively collect and anonymously submit clinical data related to the patient, pathology, and treatment characteristics (including the radiotherapy treatment plan in RT.dose format) to a single referring center.
* Ability to prospectively collect and anonymously submit DICOM (Digital Imaging and COmmunication in Medicine) files related to pre-RT magnetic resonance imaging (MRI) to a single referring center.
* Ability to collect acute toxicity data (mucositis, xerostomia, nausea, vomiting, weight loss) during radiotherapy and at three months post-treatment.
* Ability to undergo a clinical follow-up examination three months after the completion of radiotherapy.
* Willingness to provide written informed consent for the anonymous use of data for research purposes.

Exclusion Criteria:

* Patients undergoing chemotherapy treatment (neoadjuvant or concurrent with radiotherapy).
* Patients with local and/or locoregional recurrence of head and neck disease.
* Patients previously treated with oncologic interventions in the head and neck region.
* Patients with synchronous distant metastases at the time of diagnosis.
* Inability to comprehensively collect baseline data related to the patient, pathology, and treatment characteristics (including the treatment plan) and follow-up data.
* Inability to obtain written informed consent for the anonymous use of data for research purposes.

Primary outcomes:
measure: Evaluation of nausea (acute toxicity) using CTCAE V5.0
timeFrame: 3 months
Secondary outcomes:
measure: Evaluation of nausea (acute toxicity) using M.D. Anderson Symptom Inventory (MDASI-SCORE) questionnaire
timeFrame: 3 months
measure: Identification of the organs at risk most strongly correlated with the onset of nausea
timeFrame: 3 months
measure: Identification of dosimetric cutoffs for the onset of nausea
timeFrame: 3 months
measure: Comparison of dosimetric analysis between 3D conformal, IMRT and proton therapy techniques
timeFrame: 3 months
measure: Development of machine-learning predictive models for the onset of nausea
timeFrame: 1 year
Other outcomes:
Locations:
city: Ancona
country: Italy
facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona
city: Barletta
country: Italy
facility: Ospedale "Mons. Dimiccoli"
city: Benevento
country: Italy
facility: Azienda Ospedaliera S.Pio
city: Castellanza
country: Italy
facility: Ospedale MultiMedica
city: Genova
country: Italy
facility: IRCCS Ospedale Policlinico San Martino
city: Milan
country: Italy
facility: European Institute of Oncology
city: Milan
country: Italy
facility: IRCCS Ospedale San Raffaele
city: Modena
country: Italy
facility: Azienda Ospedaliero-Universitaria di Modena
city: Novara
country: Italy
facility: Azienda Ospedaliero Universitaria Ospedale Maggiore della Carità di Novara
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo
city: Roma
country: Italy
facility: Azienda Ospedaliera Complesso Ospedaliero San Giovanni - Addolorata
city: Roma
country: Italy
facility: Azienda Ospedaliero Universitaria Policlinico Umberto I
city: Roma
country: Italy
facility: Ospedale San Giovanni Calibita Fatebenefratelli Isola Tiberina
city: Sesto San Giovanni
country: Italy
facility: I.R.C.C.S. MultiMedica - Sesto San Giovanni
Study officials:
affiliation: European Institute of Oncology
name: Stefania Volpe, MD
role: PRINCIPAL_INVESTIGATOR
References: