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

NCT06506578 | Recruiting

• 1 other identifier: CHUBX 2024/14
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Benign Brain Tumor

Keywords

Radiation induced nausea; Dorsal vagal complex; Brain tumors; Brainstem; Dosimetric constraint

Outcome Measures

Primary Outcomes (1)

• Functional Living Index-Emesis (FLIE score)

  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 Outcomes (4)

• Nausea grading

  At inclusion, at day 35 of radiotherapy, at 1 and 3 months after completion of radiotherapy

• Brief Fatigue Inventory (BFI)

  At inclusion, at day 35 of radiotherapy, at 1 and 3 months after completion of radiotherapy

• Dosimetric parameters of the Dorsal Vagal Complex

  One day after completion of radiotherapy

• Dosimetric parameters of the Braintem

  One day after completion of radiotherapy

Study Arms (1)

Irradiated patients

Patients irradiated for benign brain tumor, without chemotherapy

Radiation: Radiation

Interventions

Radiation RADIATION

Radiation

Irradiated patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• More than 18 years old
• With benign brain tumor
• Irradiated with conventional fractionation (1,8-2Gy/fraction)

You may not qualify if:

• History of brain radiation
• History of head and neck radiation
• Demencia
• Concurrent chemotherapy
• Anti-nausea treatment : corticosteroids, metoclopramide, setrons, other

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (3)

CHU de Bordeaux, Service de Radiothérapie

Bordeaux, France

RECRUITING

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

Lyon, France

NOT YET RECRUITING

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

Strasbourg, France

NOT YET RECRUITING

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Radiation

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Physical Phenomena

Central Study Contacts

Charles DUPIN, MD, PhD

CONTACT

:+33(0)557623310; charles.dupin@chu-bordeaux.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2024
• First Posted: July 17, 2024
• Study Start: May 20, 2022
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)