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

Not Applicable

Completed

• Conditions: Pituitary Adenoma; Cavernous Sinus Meningioma

• Registration Number: NCT02750371
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2016-04-20
• Study First Submitted QC: 2016-04-20
• Study First Posted: 2016-04-25
• Study Start: 2016-07-27
• Primary Completion: 2022-03
• Study Completion: 2022-03
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-15
• Last Update Posted: 2023-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Autobiographical memory test (TEMPau) score	Two years after irradiation treatment end

Secondary Outcome Measures

Name	Time	Method
Revised Self Consciousness Scale (RSCS) score	One and two years after irradiation treatment end
Autobiographical memory test (TEMPau) score	One year after irradiation treatment end
Quality of life questionnaire (QLQC-30/BN20) score	One and two years after irradiation treatment end
California Verbal Learning Test (CVLT) score	One and two years after irradiation treatment end

Trial Locations

Locations (1)

University Hospital Bordeaux; 🇫🇷 Bordeaux, France