DOsimetry and Radiation Induced NAusea in Head and Neck Cancers

Last updated: March 26, 2024
Sponsor: European Institute of Oncology
Overall Status: Active - Recruiting

Phase

N/A

Condition

Head And Neck Cancer

Human Papilloma Virus (Hpv)

Nasopharyngeal Cancer

Treatment

Exclusive radiotherapy

Clinical Study ID

NCT06341985
IEO 1593
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 anunknown primary focus.
  • Curative radiotherapeutic treatment with photons or protons using 3D conformal orIntensity 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 thepatient, pathology, and treatment characteristics (including the radiotherapytreatment plan in RT.dose format) to a single referring center.
  • Ability to prospectively collect and anonymously submit DICOM (Digital Imaging andCOmmunication in Medicine) files related to pre-RT magnetic resonance imaging (MRI) toa 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 completionof radiotherapy.
  • Willingness to provide written informed consent for the anonymous use of data forresearch purposes.

Exclusion

Exclusion Criteria:

  • Patients undergoing chemotherapy treatment (neoadjuvant or concurrent withradiotherapy).
  • 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 forresearch purposes.

Study Design

Total Participants: 180
Treatment Group(s): 1
Primary Treatment: Exclusive radiotherapy
Phase:
Study Start date:
November 15, 2021
Estimated Completion Date:
December 31, 2024

Study 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).

Connect with a study center

  • Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona

    Ancona,
    Italy

    Active - Recruiting

  • Ospedale "Mons. Dimiccoli"

    Barletta,
    Italy

    Active - Recruiting

  • Azienda Ospedaliera S.Pio

    Benevento,
    Italy

    Active - Recruiting

  • Ospedale MultiMedica

    Castellanza,
    Italy

    Active - Recruiting

  • IRCCS Ospedale Policlinico San Martino

    Genova,
    Italy

    Active - Recruiting

  • European Institute of Oncology

    Milan,
    Italy

    Active - Recruiting

  • IRCCS Ospedale San Raffaele

    Milan,
    Italy

    Active - Recruiting

  • Azienda Ospedaliero-Universitaria di Modena

    Modena,
    Italy

    Active - Recruiting

  • Azienda Ospedaliero Universitaria Ospedale Maggiore della Carità di Novara

    Novara,
    Italy

    Active - Recruiting

  • Fondazione IRCCS Policlinico San Matteo

    Pavia,
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Complesso Ospedaliero San Giovanni - Addolorata

    Roma,
    Italy

    Active - Recruiting

  • Azienda Ospedaliero Universitaria Policlinico Umberto I

    Roma,
    Italy

    Active - Recruiting

  • Ospedale San Giovanni Calibita Fatebenefratelli Isola Tiberina

    Roma,
    Italy

    Active - Recruiting

  • I.R.C.C.S. MultiMedica - Sesto San Giovanni

    Sesto San Giovanni,
    Italy

    Active - Recruiting

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