Clinical trial NCT06506578: Nausea Induced by Radiation of the Dorsal Vagal Complex for Benign Brain Tumors (NausiCAA)
Official title: Characterization of Nausea Induced by Radiation of the Dorsal Vagal Complex in the Context of Benign Brain Tumors (NausiCAA)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Benign Brain Tumor
Keywords: Radiation induced nausea
Dorsal vagal complex
Brain tumors
Brainstem
Dosimetric constraint
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2024-07-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients irradiated with conventional fractionation (1,8-2Gy/fraction) for benign brain tumor

Brief summary: 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Functional Living Index-Emesis (FLIE score)
timeFrame: At inclusion, at day 35 of radiotherapy, at 1 and 3 months after completion of radiotherapy
Secondary outcomes:
measure: Nausea grading
timeFrame: At inclusion, at day 35 of radiotherapy, at 1 and 3 months after completion of radiotherapy
measure: Brief Fatigue Inventory (BFI)
timeFrame: At inclusion, at day 35 of radiotherapy, at 1 and 3 months after completion of radiotherapy
measure: Dosimetric parameters of the Dorsal Vagal Complex
timeFrame: One day after completion of radiotherapy
measure: Dosimetric parameters of the Braintem
timeFrame: One day after completion of radiotherapy
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux, Service de Radiothérapie
city: Lyon
country: France
facility: Hospices Civils de Lyon, Service d'Oncologie Radiothérapie - Hôpital Neurologique
city: Strasbourg
country: France
facility: Institut de cancérologie Strasbourg Europe (ICANS), Service d'Oncologie Radiothérapie
Study officials:
References: