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Effect of Irradiation of the Cavernous Sinus and the Sellar Region on Autobiographical Memory (ISOMAB)

Primary Purpose

Cavernous Sinus Meningioma, Pituitary Adenoma

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Evaluation of autobiographical memory
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Cavernous Sinus Meningioma focused on measuring Cavernous sinus meningioma, Pituitary adenoma, Hippocampus, Irradiation, Autobiographical memory

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age between 35 and 65.
  • Patient with:

    • meningioma of the cavernous sinus for which radiotherapy is planned
    • or a pituitary adenoma for which radiotherapy is planned
  • French Mother tongue
  • Person affiliated to national insurance
  • Person who give its verbal agreement to participate

Exclusion Criteria:

  • Presence of a serious psychiatric disorder (major depression, psychotic disorders, etc.) and central nervous system disease (epilepsy, multiple sclerosis, etc.).
  • Treatment with chemotherapy
  • General intellectual abilities deficient (IQ <80)
  • Extension front of their meningioma
  • Deficient Language Skills.

Sites / Locations

  • University Hospital Bordeaux

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with brain tumors treated by radiotherapy

Arm Description

Patients with: - meningioma of the cavernous sinus for which radiotherapy is planned Or - a pituitary adenoma for which radiotherapy is planned

Outcomes

Primary Outcome Measures

Autobiographical memory test (TEMPau) score

Secondary Outcome Measures

Autobiographical memory test (TEMPau) score
Revised Self Consciousness Scale (RSCS) score
Quality of life questionnaire (QLQC-30/BN20) score
California Verbal Learning Test (CVLT) score

Full Information

First Posted
April 20, 2016
Last Updated
March 15, 2023
Sponsor
University Hospital, Bordeaux
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1. Study Identification

Unique Protocol Identification Number
NCT02750371
Brief Title
Effect of Irradiation of the Cavernous Sinus and the Sellar Region on Autobiographical Memory
Acronym
ISOMAB
Official Title
Effect of Irradiation of the Cavernous Sinus and the Sellar Region on Autobiographical Memory
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
July 27, 2016 (Actual)
Primary Completion Date
March 2022 (Actual)
Study Completion Date
March 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Several studies showed that radiotherapy as brain tumors treatment may affect cognition. It was observed that durable memory impairments could arise at irradiated patients if radiotherapy is applied on medial temporal lobes. However, results concerned studies of anterograde memory and none, this day, estimates the impact of radiotherapy on autobiographical memory which also involves hippocampus. The aim of this study is to evaluate effects of cavernous sinus or sellar region irradiation on autobiographical memory. Thirty 35 to 65 years old patients, with cavernous sinus meningioma or pituitary adenoma for who radiotherapy is indicated will be recruited.
Detailed Description
Several studies showed that radiotherapy as brain tumors treatment may affect cognition. It was observed that durable memory impairments could arise at irradiated patients if radiotherapy is applied on medial temporal lobes. However, results concerned studies of anterograde memory and none, this day, estimates the impact of radiotherapy on autobiographical memory which also involves hippocampus, as specified in Nadel and Moscovitch model, the Multiple Trace Theory. Autobiographical memory impairment issue is fundamental for identity construction. Prevent those impairments is important to quality of life improvement after such treatments. The aim of this study is to evaluate effects of cavernous sinus or sellar region irradiation on autobiographical memory. A pilot study was conducted with 10 patients affected by left cavernous sinus meningioma divided in two groups: the first one with untreated patients and the second one with patients who received cavernous sinus irradiation between 2 and 5 years before pilot study. This study indicated autobiographical memory deterioration in two groups and a worsening in treated group. Study limits did not allow us to draw conclusions. That is why, sample size will be extended and patients with cavernous sinus meningioma or pituitary adenoma will be recruited because of proximity between cavernous sinus, pituitary gland and hippocampus. Investigators wish to recruit 30 patients with cavernous sinus and meningioma. Investigators hope for confirm our results from pilot study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cavernous Sinus Meningioma, Pituitary Adenoma
Keywords
Cavernous sinus meningioma, Pituitary adenoma, Hippocampus, Irradiation, Autobiographical memory

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients with brain tumors treated by radiotherapy
Arm Type
Experimental
Arm Description
Patients with: - meningioma of the cavernous sinus for which radiotherapy is planned Or - a pituitary adenoma for which radiotherapy is planned
Intervention Type
Other
Intervention Name(s)
Evaluation of autobiographical memory
Intervention Description
Patients will answer several questionnaires one and two years after irradiation treatment end.
Primary Outcome Measure Information:
Title
Autobiographical memory test (TEMPau) score
Time Frame
Two years after irradiation treatment end
Secondary Outcome Measure Information:
Title
Autobiographical memory test (TEMPau) score
Time Frame
One year after irradiation treatment end
Title
Revised Self Consciousness Scale (RSCS) score
Time Frame
One and two years after irradiation treatment end
Title
Quality of life questionnaire (QLQC-30/BN20) score
Time Frame
One and two years after irradiation treatment end
Title
California Verbal Learning Test (CVLT) score
Time Frame
One and two years after irradiation treatment end

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age between 35 and 65. Patient with: meningioma of the cavernous sinus for which radiotherapy is planned or a pituitary adenoma for which radiotherapy is planned French Mother tongue Person affiliated to national insurance Person who give its verbal agreement to participate Exclusion Criteria: Presence of a serious psychiatric disorder (major depression, psychotic disorders, etc.) and central nervous system disease (epilepsy, multiple sclerosis, etc.). Treatment with chemotherapy General intellectual abilities deficient (IQ <80) Extension front of their meningioma Deficient Language Skills.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivier BRANCHARD
Organizational Affiliation
University Hospital, Bordeaux
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital Bordeaux
City
Bordeaux
ZIP/Postal Code
33076
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Patient could request investigator an access to IPD according to French regulation (act No. 78-17 of 6 January 1978 on data processing, data files and individual liberties, amended by act No. 2004-801 of 6 August 2004).
Citations:
PubMed Identifier
9142752
Citation
Nadel L, Moscovitch M. Memory consolidation, retrograde amnesia and the hippocampal complex. Curr Opin Neurobiol. 1997 Apr;7(2):217-27. doi: 10.1016/s0959-4388(97)80010-4.
Results Reference
background
PubMed Identifier
17382578
Citation
Cabeza R, St Jacques P. Functional neuroimaging of autobiographical memory. Trends Cogn Sci. 2007 May;11(5):219-27. doi: 10.1016/j.tics.2007.02.005. Epub 2007 Mar 26.
Results Reference
background
PubMed Identifier
12874001
Citation
Mizumatsu S, Monje ML, Morhardt DR, Rola R, Palmer TD, Fike JR. Extreme sensitivity of adult neurogenesis to low doses of X-irradiation. Cancer Res. 2003 Jul 15;63(14):4021-7.
Results Reference
background

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Effect of Irradiation of the Cavernous Sinus and the Sellar Region on Autobiographical Memory

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