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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

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 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, 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.


Sponsor: University Hospital, Bordeaux

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

Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: University Hospital, Bordeaux

Dates:
Date Received: April 20, 2016
Date Started: July 2016
Date Completion: January 2021
Last Updated: July 11, 2016
Last Verified: July 2016