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

July 29, 2025 updated by: University Hospital, Bordeaux

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Bordeaux, France
      • Lyon, France
        • Not yet recruiting
        • Hospices Civils de Lyon, Service d'Oncologie Radiothérapie - Hôpital Neurologique
        • Contact:
      • Strasbourg, France
        • Not yet recruiting
        • Institut de cancérologie Strasbourg Europe (ICANS), Service d'Oncologie Radiothérapie
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients irradiated with conventional fractionation (1,8-2Gy/fraction) for benign brain tumor

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Irradiated patients
Patients irradiated for benign brain tumor, without chemotherapy
Radiation: Radiation
Radiation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At inclusion, at day 35 of radiotherapy, at 1 and 3 months after completion of radiotherapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nausea grading
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
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
Validated score with 9 items of Likert scale concerning fatigue
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
Mean Dose to the Dorsal Vagal Complex
One day after completion of radiotherapy
Dosimetric parameters of the Braintem
Time Frame: One day after completion of radiotherapy
Mean Dose to the Braintem
One day after completion of radiotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2022

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

June 19, 2024

First Submitted That Met QC Criteria

July 15, 2024

First Posted (Actual)

July 17, 2024

Study Record Updates

Last Update Posted (Actual)

July 30, 2025

Last Update Submitted That Met QC Criteria

July 29, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2024/14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Benign Brain Tumor

Clinical Trials on Radiation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Lebanon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe