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Recruiting NCT06506578

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

— Observational Benign Brain Tumor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Radiation.
Who it may be relevant to
Registry conditions: Benign Brain Tumor. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Radiation Radiation
    Radiation

Primary outcome measures

  • Functional Living Index-Emesis (FLIE score) [Time frame: At inclusion, at day 35 of radiotherapy, at 1 and 3 months after completion of radiotherapy]
Secondary outcome measures (4)
  • 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

France · 3 centers
  • 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

Identifiers

NCT: NCT06506578 · CHUBX 2024/14

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗