Nausea Induced by Radiation of the Dorsal Vagal Complex for Benign Brain Tumors (NausiCAA)

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Nausea Induced by Radiation of the Dorsal Vagal Complex for Benign Brain Tumors (NausiCAA)

Study Purpose

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Unknown
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06506578
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University Hospital, Bordeaux
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	France
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Benign Brain Tumor

Additional Details

Patients irradiated to the brain frequently experience nausea. The dorsal vagal complex (DVC) area is a specific brainstem zone and has been identified as likely responsible for nausea. Existing clinical studies show correlation between dose to the DVC and nausea, but they concern tumors of the airways and upper digestive tract, where there are many confounding factors. A retrospective study was carried out a in the radiotherapy oncology department of Bordeaux University Hospital on 102 patients irradiated for a benign brain tumor. This study showed that DVC irradiation was significantly associated with the onset of nausea. However, this symptom alters the quality of life on a daily basis. The objective of this prospective, multicenter, non-interventional study is to evaluate, using nausea validated questionnaires : Functional Living Index-Emesis (FLIE score), the correlation between DVC irradiation and nausea in benign brain tumors, at the end of radiotherapy, 1 month later and 3 months later. Fatigue associated with brain irradiation will also be studied with BFI (Brief Fatigue Inventory). If there is an established link, a secondary dose constraint on this structure will be able to be proposed to reduce nausea in these radiotherapy indications.

Arms & Interventions

Arms

: Irradiated patients

Patients irradiated for benign brain tumor, without chemotherapy

Interventions

Radiation: - Radiation

Radiation

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