DOsimetry and Radiation Induced NAusea in Head and Neck Cancers

NCT06341985 | Recruiting

• 1 other identifier: IEO 1593
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 14

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.

Conditions

Head and Neck Cancer

Keywords

Head and Neck Cancer; Exclusive Radiotherapy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Evaluation of nausea (acute toxicity) using M.D. Anderson Symptom Inventory (MDASI-SCORE) questionnaire

  3 months

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

  3 months

• Identification of dosimetric cutoffs for the onset of nausea

  3 months

• Comparison of dosimetric analysis between 3D conformal, IMRT and proton therapy techniques

  3 months

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

  1 year

Study Arms (1)

Exclusive Radiotherapy Treatment

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

Radiation: Exclusive radiotherapy

Interventions

Exclusive radiotherapy RADIATION

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

Exclusive Radiotherapy Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• European Institute of Oncology: lead

Study Sites (14)

Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona

Ancona, Italy

RECRUITING

Ospedale "Mons. Dimiccoli"

Barletta, Italy

RECRUITING

Azienda Ospedaliera S.Pio

Benevento, Italy

RECRUITING

Ospedale MultiMedica

Castellanza, Italy

RECRUITING

IRCCS Ospedale Policlinico San Martino

Genova, Italy

RECRUITING

European Institute of Oncology

Milan, Italy

RECRUITING

IRCCS Ospedale San Raffaele

Milan, Italy

RECRUITING

Azienda Ospedaliero-Universitaria di Modena

Modena, Italy

RECRUITING

Azienda Ospedaliero Universitaria Ospedale Maggiore della Carità di Novara

Novara, Italy

RECRUITING

Fondazione IRCCS Policlinico San Matteo

Pavia, Italy

RECRUITING

Azienda Ospedaliera Complesso Ospedaliero San Giovanni - Addolorata

Roma, Italy

RECRUITING

Azienda Ospedaliero Universitaria Policlinico Umberto I

Roma, Italy

RECRUITING

Ospedale San Giovanni Calibita Fatebenefratelli Isola Tiberina

Roma, Italy

RECRUITING

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

Sesto San Giovanni, Italy

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Stefania Volpe, MD

  European Institute of Oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefania Volpe, MD

CONTACT

+3902574892418; stefania.volpe@ieo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2024
• First Posted: April 2, 2024
• Study Start: November 15, 2021
• Primary Completion: November 15, 2024
• Study Completion: December 31, 2024
• Last Updated: April 2, 2024

Record last verified: 2024-03

Locations

IT (14)