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NCT Number: NCT06506578

Nausea Induced by Radiation of the Dorsal Vagal Complex for 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Bordeaux, Service de Radiothérapie, Bordeaux, France

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radiation

Radiation

Radiation

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. Dosimetric parameters of the Dorsal Vagal Complex

    Time frame: One day after completion of radiotherapy

    Mean Dose to the Dorsal Vagal Complex

  4. Dosimetric parameters of the Braintem

    Time frame: One day after completion of radiotherapy

    Mean Dose to the Braintem

Study contacts

Contact information is provided by the study sponsor or research team.

Charles DUPIN, MD, PhD

CONTACT

[email protected]

:+33(0)557623310

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

Characterization of Nausea Induced by Radiation of the Dorsal Vagal Complex in the Context of Benign Brain Tumors (NausiCAA)

Acronym: NausiCAA

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jul 17, 2024
Registry last updated
Jul 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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