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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Irradiated patients | Patients irradiated for benign brain tumor, without chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiation | Radiation | Radiation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Nausea grading | Common Terminology Criteria for Adverse Events (CTCAE) V5.0 | At inclusion, at day 35 of radiotherapy, at 1 and 3 months after completion of radiotherapy |
| Brief Fatigue Inventory (BFI) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients irradiated with conventional fractionation (1,8-2Gy/fraction) for benign brain tumor
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Charles DUPIN, MD, PhD | Contact | :+33(0)557623310 | charles.dupin@chu-bordeaux.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Bordeaux, Service de Radiothérapie | Recruiting | Bordeaux | France |
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| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D011827 | Radiation |
| ID | Term |
|---|---|
| D055585 | Physical Phenomena |
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Validated score with 9 items of Likert scale concerning fatigue
| At inclusion, at day 35 of radiotherapy, at 1 and 3 months after completion of radiotherapy |
| Dosimetric parameters of the Dorsal Vagal Complex | Mean Dose to the Dorsal Vagal Complex | One day after completion of radiotherapy |
| Dosimetric parameters of the Braintem | Mean Dose to the Braintem | One day after completion of radiotherapy |
| Hospices Civils de Lyon, Service d'Oncologie Radiothérapie - Hôpital Neurologique | Not yet recruiting | Lyon | France |
|
| Institut de cancérologie Strasbourg Europe (ICANS), Service d'Oncologie Radiothérapie | Not yet recruiting | Strasbourg | France |
|
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |