Radiation
RadiationRadiation
NCT Number: NCT06506578
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.
The aim of this study is to establish a ling between radiation dose to the DVC and nausea. Defining a dose threshold to the DVC will allow radiation oncologists to optimize radiation dose distribution and reduce nausea in patients.
Interested in participating?
Request Info18 year and older
All sexes
Observational
CHU de Bordeaux, Service de Radiothérapie, Bordeaux, France
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.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Radiation
Time frame: At inclusion, at day 35 of radiotherapy, at 1 and 3 months after completion of radiotherapy
Validated score with 9 items of Likert scale concerning nausea
Time frame: At inclusion, at day 35 of radiotherapy, at 1 and 3 months after completion of radiotherapy
Common Terminology Criteria for Adverse Events (CTCAE) V5.0
Time frame: At inclusion, at day 35 of radiotherapy, at 1 and 3 months after completion of radiotherapy
Validated score with 9 items of Likert scale concerning fatigue
Time frame: One day after completion of radiotherapy
Mean Dose to the Dorsal Vagal Complex
Time frame: One day after completion of radiotherapy
Mean Dose to the Braintem
Contact information is provided by the study sponsor or research team.
University Hospital, Bordeaux
Other
Characterization of Nausea Induced by Radiation of the Dorsal Vagal Complex in the Context of Benign Brain Tumors (NausiCAA)
Acronym: NausiCAA
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