Benign Brain Tumor
Conditions
Keywords
Radiation induced nausea, Dorsal vagal complex, Brain tumors, Brainstem, Dosimetric constraint
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.
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
RADIATIONRadiation
Radiation
Sponsors
University Hospital, Bordeaux
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional Living Index-Emesis (FLIE score) | At inclusion, at day 35 of radiotherapy, at 1 and 3 months after completion of radiotherapy | Validated score with 9 items of Likert scale concerning nausea |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nausea grading | At inclusion, at day 35 of radiotherapy, at 1 and 3 months after completion of radiotherapy | Common Terminology Criteria for Adverse Events (CTCAE) V5.0 |
| Brief Fatigue Inventory (BFI) | At inclusion, at day 35 of radiotherapy, at 1 and 3 months after completion of radiotherapy | Validated score with 9 items of Likert scale concerning fatigue |
| Dosimetric parameters of the Dorsal Vagal Complex | One day after completion of radiotherapy | Mean Dose to the Dorsal Vagal Complex |
| Dosimetric parameters of the Braintem | One day after completion of radiotherapy | Mean Dose to the Braintem |
Countries
France
Outcome results
None listed