Analyzing nausea and vomiting in head and neck cancer patients receiving radiotherapy
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)
This study is trying to see if certain treatment details can help explain why some head and neck cancer patients feel nausea and vomiting after receiving radiation therapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 180 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | European Institute of Oncology Academic / other |
| Drugs / interventions | chemotherapy, Radiation |
| Locations | 14 sites (Ancona and 13 other locations) |
| Trial ID | NCT06341985 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the correlation between dosimetric parameters and Radiation Associated Nausea and Vomiting (RANV) in patients with head and neck cancer undergoing exclusive radiotherapy. It focuses on patients treated with Intensity Modulated Radiation Therapy (IMRT) and seeks to identify clinical and dosimetric risk factors associated with RANV. By collecting and analyzing data on patient-reported symptoms and treatment characteristics, the study aims to enhance understanding of the toxicity profiles linked to modern radiotherapy techniques. The findings could help improve patient management and treatment planning.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a primary diagnosis of head and neck cancer receiving exclusive radiotherapy.
Not a fit: Patients undergoing concurrent chemotherapy or those with non-primary head and neck neoplasms may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better management strategies for minimizing nausea and vomiting in head and neck cancer patients undergoing radiotherapy.
How similar studies have performed: While some studies have explored similar topics, this study's focus on exclusively radiotherapy without concurrent chemotherapy is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Ancona and 13 other locations
- 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)
Study contacts
- Principal investigator: Stefania Volpe, MD — European Institute of Oncology
- Study coordinator: Stefania Volpe, MD
- Email: stefania.volpe@ieo.it
- Phone: +3902574892418
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.