Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06506578
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-06-19
Brief Title:
Nausea Induced by Radiation of the Dorsal Vagal Complex for Benign Brain Tumors NausiCAA
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Characterization of Nausea Induced by Radiation of the Dorsal Vagal Complex in the Context of Benign Brain Tumors NausiCAA
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NausiCAA
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None