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

Pituitary Adenoma Clinical Trial

— ISOMAB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02750371
• Other study ID #: CHUBX 2015/03
• Status: Completed
• Phase: N/A
• Start date: July 27, 2016
• Est. completion date: March 2022

Study information

• Verified date: March 2023
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: March 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adenoma
• Cavernous Sinus Meningioma
• Meningioma
• Pituitary Adenoma
• Pituitary Diseases
• Pituitary Neoplasms

Intervention

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

Locations

Country	Name	City	State
France	University Hospital Bordeaux	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Autobiographical memory test (TEMPau) score		Two years after irradiation treatment end
Secondary	Autobiographical memory test (TEMPau) score		One year after irradiation treatment end
Secondary	Revised Self Consciousness Scale (RSCS) score		One and two years after irradiation treatment end
Secondary	Quality of life questionnaire (QLQC-30/BN20) score		One and two years after irradiation treatment end
Secondary	California Verbal Learning Test (CVLT) score		One and two years after irradiation treatment end