DOsimetry and Radiation Induced NAusea in Head and Neck Cancers

N/AUnknownNCT06341985

European Institute of Oncology180 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

180

Conditions

Head and Neck Cancer

Interventions

Exclusive radiotherapyRADIATION

Curative radiotherapy treatment using 3D conformal or Intensity Modulated Radiation Therapy (IMRT) techniques.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (14)

Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona

Ancona, Italy

RECRUITING

Ospedale "Mons. Dimiccoli"

Barletta, Italy

Outcomes

Primary Outcomes

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

Time frame: 3 months

Secondary Outcomes

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

Time frame: 3 months

Identification of the organs at risk most strongly correlated with the onset of nausea

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)

Time frame: 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

Time frame: 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

Time frame: 3 months

Development of machine-learning predictive models for the onset of nausea

Central Contacts

Stefania Volpe, MD

CONTACT

+3902574892418 stefania.volpe@ieo.it

Data from ClinicalTrials.gov

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