Nausea Induced by Radiation of the Dorsal Vagal Complex for Benign Brain Tumors (NausiCAA)
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Radiation.
- Кому может быть актуально
- Состояния в реестре: Benign Brain Tumor. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Франция
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Characterization of Nausea Induced by Radiation of the Dorsal Vagal Complex in the Context of Benign Brain Tumors (NausiCAA)
Обзор
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.
Подробное описание
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.
Вмешательства
- Лучевая терапия Radiation
Radiation
Первичные конечные точки
- Functional Living Index-Emesis (FLIE score) [Срок оценки: At inclusion, at day 35 of radiotherapy, at 1 and 3 months after completion of radiotherapy]
Вторичные конечные точки (4)
- Nausea grading [Срок оценки: At inclusion, at day 35 of radiotherapy, at 1 and 3 months after completion of radiotherapy]
- Brief Fatigue Inventory (BFI) [Срок оценки: At inclusion, at day 35 of radiotherapy, at 1 and 3 months after completion of radiotherapy]
- Dosimetric parameters of the Dorsal Vagal Complex [Срок оценки: One day after completion of radiotherapy]
- Dosimetric parameters of the Braintem [Срок оценки: One day after completion of radiotherapy]
Критерии участия
Критерии включения
- More than 18 years old
- With benign brain tumor
- Irradiated with conventional fractionation (1,8-2Gy/fraction)
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Франция · 3 центра
- 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
Идентификаторы
NCT: NCT06506578 · CHUBX 2024/14