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

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ClinicalTrials.gov Identifier: NCT02750371
Recruitment Status : Recruiting
First Posted : April 25, 2016
Last Update Posted : January 3, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

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.


Condition or disease Intervention/treatment Phase
Cavernous Sinus Meningioma Pituitary Adenoma Other: Evaluation of autobiographical memory Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effect of Irradiation of the Cavernous Sinus and the Sellar Region on Autobiographical Memory
Actual Study Start Date : July 27, 2016
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Patients with brain tumors treated by radiotherapy

Patients with:

- meningioma of the cavernous sinus for which radiotherapy is planned

Or

- a pituitary adenoma for which radiotherapy is planned

Other: Evaluation of autobiographical memory
Patients will answer several questionnaires one and two years after irradiation treatment end.




Primary Outcome Measures :
  1. Autobiographical memory test (TEMPau) score [ Time Frame: Two years after irradiation treatment end ]

Secondary Outcome Measures :
  1. Autobiographical memory test (TEMPau) score [ Time Frame: One year after irradiation treatment end ]
  2. Revised Self Consciousness Scale (RSCS) score [ Time Frame: One and two years after irradiation treatment end ]
  3. Quality of life questionnaire (QLQC-30/BN20) score [ Time Frame: One and two years after irradiation treatment end ]
  4. California Verbal Learning Test (CVLT) score [ Time Frame: One and two years after irradiation treatment end ]


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Ages Eligible for Study:   35 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02750371


Contacts
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Contact: Charlotte PLANCHON 05 56 79 55 77 ext +33 charlotte.planchon@chu-bordeaux.fr
Contact: Olivier BRANCHARD 05 56 79 55 77 ext +33 olivier.branchard@chu-bordeaux.fr

Locations
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France
University Hospital Bordeaux Recruiting
Bordeaux, France, 33076
Contact: Charlotte PLANCHON    05 56 79 55 77 ext +33    charlotte.planchon@chu-bordeaux.fr   
Contact: Olivier BRANCHARD    05 56 79 55 77 ext +33    olivier.branchard@chu-bordeaux.fr   
Principal Investigator: Charlotte PLANCHON         
Sub-Investigator: Emmanuel CUNY, MD-PhD         
Sub-Investigator: Hugues LOISEAU, MD-PhD         
Sub-Investigator: Charles DUPIN, MD         
Sub-Investigator: Aymeri HUCHET, MD         
Sub-Investigator: Antoine TABARIN, MD-PhD         
Sub-Investigator: Marie-Laure NUNES, MD         
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
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Study Chair: Olivier BRANCHARD University Hospital, Bordeaux

Publications:
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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT02750371     History of Changes
Other Study ID Numbers: CHUBX 2015/03
First Posted: April 25, 2016    Key Record Dates
Last Update Posted: January 3, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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).
Keywords provided by University Hospital, Bordeaux:
Cavernous sinus meningioma
Pituitary adenoma
Hippocampus
Irradiation
Autobiographical memory
Additional relevant MeSH terms:
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Pituitary Neoplasms
Pituitary Diseases
Adenoma
Meningioma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Neoplasms, Nerve Tissue
Neoplasms, Vascular Tissue
Meningeal Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Hypothalamic Neoplasms
Supratentorial Neoplasms
Brain Neoplasms