Clinical trial NCT02750371: Effect of Irradiation of the Cavernous Sinus and the Sellar Region on Autobiographical Memory
Official title: Effect of Irradiation of the Cavernous Sinus and the Sellar Region on Autobiographical Memory
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cavernous Sinus Meningioma
Pituitary Adenoma
Keywords: Cavernous sinus meningioma
Pituitary adenoma
Hippocampus
Irradiation
Autobiographical memory
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2016-04-25
Enrollment: 17
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: Autobiographical memory test (TEMPau) score
timeFrame: Two years after irradiation treatment end
Secondary outcomes:
measure: Autobiographical memory test (TEMPau) score
timeFrame: One year after irradiation treatment end
measure: Revised Self Consciousness Scale (RSCS) score
timeFrame: One and two years after irradiation treatment end
measure: Quality of life questionnaire (QLQC-30/BN20) score
timeFrame: One and two years after irradiation treatment end
measure: California Verbal Learning Test (CVLT) score
timeFrame: One and two years after irradiation treatment end
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: University Hospital Bordeaux
Study officials:
affiliation: University Hospital, Bordeaux
name: Olivier BRANCHARD
role: STUDY_CHAIR
References:
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.
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.
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.