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

University Hospital of Bordeaux

Status: Enrolling

Conditions: Benign Brain Tumor

Treatments: Radiation: Radiation

Study type: Observational

Funder types: Other

Identifiers

NCT06506578

CHUBX 2024/14

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 1 patient group

Irradiated patients

Description:

Patients irradiated for benign brain tumor, without chemotherapy

Treatment:

Radiation: Radiation