Benign Brain TumorNausiCAANCT06506578
Nausea Induced by Radiation of the Dorsal Vagal Complex for Benign Brain Tumors (NausiCAA)
An observational study of Benign Brain Tumor, run by University Hospital, Bordeaux at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Benign Brain Tumor
- What is being tested?
- Radiation
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 3 sitesFrance
- Study dates
- 20 May 2022to 9 Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients irradiated with conventional fractionation (1,8-2Gy/fraction) for benign brain tumor
Who may be able to join
- More than 18 years old
- With benign brain tumor
- Irradiated with conventional fractionation (1,8-2Gy/fraction)
Who cannot join
- 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 locations and contacts
3 sites in 1 country.
France3 sites
CHU de Bordeaux, Service de Radiothérapie
Bordeaux
Hospices Civils de Lyon, Service d'Oncologie Radiothérapie - Hôpital Neurologique
Lyon
Institut de cancérologie Strasbourg Europe (ICANS), Service d'Oncologie Radiothérapie
Strasbourg
About this study
Official title: Characterization of Nausea Induced by Radiation of the Dorsal Vagal Complex in the Context of Benign Brain Tumors (NausiCAA)
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.
Read the 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.
- Conditions
- Benign Brain Tumor
- Being tested
- Radiation
- Keywords
- Radiation induced nausea, Dorsal vagal complex, Brain tumors, Brainstem, Dosimetric constraint
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiationRadiation
Radiation
| Study group | Role | What they receive |
|---|---|---|
| Irradiated patients | Patients irradiated for benign brain tumor, without chemotherapy Receives: Radiation: Radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Living Index-Emesis (FLIE score)
Validated score with 9 items of Likert scale concerning nausea
Measured: At inclusion, at day 35 of radiotherapy, at 1 and 3 months after completion of radiotherapy
Secondary outcomes (4)
Nausea grading
Common Terminology Criteria for Adverse Events (CTCAE) V5.0
Measured: At inclusion, at day 35 of radiotherapy, at 1 and 3 months after completion of radiotherapy
Brief Fatigue Inventory (BFI)
Validated score with 9 items of Likert scale concerning fatigue
Measured: At inclusion, at day 35 of radiotherapy, at 1 and 3 months after completion of radiotherapy
Dosimetric parameters of the Dorsal Vagal Complex
Mean Dose to the Dorsal Vagal Complex
Measured: One day after completion of radiotherapy
Dosimetric parameters of the Braintem
Mean Dose to the Braintem
Measured: One day after completion of radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start20 May 2022
- Primary completion9 Aug 2026
- Study completion9 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Brain TumorStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06506578
- Sponsor's protocol ID
- CHUBX 2024/14
- Acronym
- NausiCAA
- Status last verified
- Aug 2026
- First submitted
- 19 Jun 2024
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Nausea Induced by Radiation of the Dorsal Vagal Complex in the Context of Benign Brain Tumors (NausiCAA)
- ClinicalTrials.gov ID
- NCT06506578
- Acronym / sponsor ID
- NausiCAA / CHUBX 2024/14
- Conditions
- Benign Brain Tumor
- Keywords
- Radiation induced nausea, Dorsal vagal complex, Brain tumors, Brainstem, Dosimetric constraint
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 20 May 2022 (actual)
- Primary completion
- 9 Aug 2026 (actual)
- Study completion
- 9 Aug 2026 (actual)
- First posted
- 17 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Irradiated patients | – | Radiation: RadiationPatients irradiated for benign brain tumor, without chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients irradiated with conventional fractionation (1,8-2Gy/fraction) for benign brain tumor
Key inclusion criteria (3 listed)
- More than 18 years old
- With benign brain tumor
- Irradiated with conventional fractionation (1,8-2Gy/fraction)
Key exclusion criteria (6 listed)
- History of brain radiation
- History of head and neck radiation
- Demencia
- Concurrent chemotherapy
- Nausea at the time of inclusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RadiationRadiation | Radiation | Irradiated patients |
Primary outcome
Functional Living Index-Emesis (FLIE score)
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
4 secondary outcomes
Nausea grading
Time frame: At inclusion, at day 35 of radiotherapy, at 1 and 3 months after completion of radiotherapy
Brief Fatigue Inventory (BFI)
Time frame: At inclusion, at day 35 of radiotherapy, at 1 and 3 months after completion of radiotherapy
Dosimetric parameters of the Dorsal Vagal Complex
Time frame: One day after completion of radiotherapy
Dosimetric parameters of the Braintem
Time frame: One day after completion of radiotherapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Benign Brain Tumor, run by University Hospital, Bordeaux at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Living Index-Emesis (FLIE score) (time frame: At inclusion, at day 35 of radiotherapy, at 1 and 3 months after completion of radiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.