Understanding nausea caused by radiation in patients with benign brain tumors
Characterization of Nausea Induced by Radiation of the Dorsal Vagal Complex in the Context of Benign Brain Tumors (NausiCAA)
This study is trying to see if the amount of radiation given to a specific area in the brain affects how much nausea patients with benign brain tumors feel during and after treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Bordeaux Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 3 sites (Bordeaux and 2 other locations) |
| Trial ID | NCT06506578 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the relationship between radiation dose to the dorsal vagal complex (DVC) and the incidence of nausea in patients with benign brain tumors. By utilizing validated questionnaires, the study will assess nausea levels at the end of radiotherapy and at one and three months post-treatment. The goal is to establish a dose threshold for the DVC that could help radiation oncologists optimize treatment plans and minimize nausea. This multicenter, non-interventional approach builds on previous findings linking DVC irradiation to nausea, but focuses specifically on benign brain tumors.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with a diagnosis of benign brain tumors who are undergoing conventional radiation therapy.
Not a fit: Patients with a history of brain or head and neck radiation, concurrent chemotherapy, or those currently experiencing nausea may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved quality of life for patients by reducing radiation-induced nausea.
How similar studies have performed: Previous studies have shown a correlation between DVC irradiation and nausea in other contexts, but this specific approach in benign brain tumors is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * More than 18 years old * With benign brain tumor * Irradiated with conventional fractionation (1,8-2Gy/fraction) Exclusion Criteria: * History of brain radiation * History of head and neck radiation * Demencia * Concurrent chemotherapy * Nausea at the time of inclusion * Anti-nausea treatment : corticosteroids, metoclopramide, setrons, other
Where this trial is running
Bordeaux and 2 other locations
- CHU de Bordeaux, Service de Radiothérapie — Bordeaux, France (Recruiting)
- Hospices Civils de Lyon, Service d'Oncologie Radiothérapie - Hôpital Neurologique — Lyon, France (Not_yet_recruiting)
- Institut de cancérologie Strasbourg Europe (ICANS), Service d'Oncologie Radiothérapie — Strasbourg, France (Not_yet_recruiting)
Study contacts
- Study coordinator: Charles DUPIN, MD, PhD
- Email: charles.dupin@chu-bordeaux.fr
- Phone: :+33(0)557623310
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.