Clinical trial · Observational
Nausea Induced by Radiation of the Dorsal Vagal Complex for Benign Brain Tumors (NausiCAA)
Characterization of Nausea Induced by Radiation of the Dorsal Vagal Complex in the Context of Benign Brain Tumors (NausiCAA)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Benign Brain Tumor | Benign Brain Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Irradiated patients
- description
- Patients irradiated for benign brain tumor, without chemotherapy
- interventionNames
- Radiation: Radiation
Primary outcomes (1)
- measure
- Functional Living Index-Emesis (FLIE score)
- timeFrame
- At inclusion, at day 35 of radiotherapy, at 1 and 3 months after completion of radiotherapy
- description
- Validated score with 9 items of Likert scale concerning nausea
Secondary outcomes (4)
- measure
- Nausea grading
- timeFrame
- At inclusion, at day 35 of radiotherapy, at 1 and 3 months after completion of radiotherapy
- description
- Common Terminology Criteria for Adverse Events (CTCAE) V5.0
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available