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

Last updated: July 15, 2024
Sponsor: University Hospital, Bordeaux
Overall Status: Active - Recruiting

Phase

N/A

Condition

Colic

Lactose Intolerance

Stomach Discomfort

Treatment

Radiation

Clinical Study ID

NCT06506578
CHUBX 2024/14
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • More than 18 years old

  • With benign brain tumor

  • Irradiated with conventional fractionation (1,8-2Gy/fraction)

Exclusion

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 Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Radiation
Phase:
Study Start date:
May 20, 2022
Estimated Completion Date:
June 30, 2026

Study 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.

Connect with a study center

  • CHU de Bordeaux, Service de Radiothérapie

    Bordeaux,
    France

    Active - Recruiting

  • Hospices Civils de Lyon, Service d'Oncologie Radiothérapie - Hôpital Neurologique

    Lyon,
    France

    Site Not Available

  • Institut de cancérologie Strasbourg Europe (ICANS), Service d'Oncologie Radiothérapie

    Strasbourg,
    France

    Site Not Available

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