Impact of Cancer on Memory Functioning: Understanding Disorders Using Approaches in Neuropsychology and Neuroimaging

Phase 2

Terminated

• Conditions: Healthy; Breast Cancer
• Interventions: Procedure: cognitive tests and cerebral IRM

• Registration Number: NCT01332916
• Lead Sponsor: Centre Francois Baclesse

Brief Summary

The purpose of this study is to investigate memory problems in patients with cancer.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2011-04-08
• Study First Submitted QC: 2011-04-08
• Study First Posted: 2011-04-11
• Status Verified: 2012-05
• Primary Completion: 2013-12
• Study Completion: 2014-04
• Last Update Submitted: 2014-04-24
• Last Update Posted: 2014-04-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Traduction (français > anglais)

• Metastatic
• Cancer of the breast other than primitive
• Patients with paraneoplastic syndrome
• Patients under 45 years
• Patients whose achievement is below level 3 'end of primary schooling "(scale Barbizet)
• Patients with adjuvant chemotherapy is associated with targeted therapy
• Patients who have received other cancer treatments (chemotherapy or radiotherapy brain)
• Contraindication to the implementation of an MRI (claustrophobia, metal objects in the body)
• disorders of higher functions existing in the administration of chemotherapy
• Neurologic earlier
• Pathology psychiatric evolutionary
• Refusal of participation
• Patients unable to meet the cognitive tests
• Drug use
• Heavy drinking

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
healthy volunteers (controls) aged 45 and over	cognitive tests and cerebral IRM	healthy volunteers (controls) aged 45 and over
patients aged 45 and over group	cognitive tests and cerebral IRM	patients aged 45 and over with breast cancer and should receive an adjuvant chemotherapy

Primary Outcome Measures

Name	Time	Method
Assess the relationship between memory impairment and brain dysfunction	Before chemotherapy (baseline), end of chemotherapy and follow-up up to 12 months after chemotherapy	The main objective is to assess the relationship between memory impairment and brain dysfunction in patients treated with adjuvant chemotherapy for breast cancer (before and after treatment), compared to a group of healthy subjects.

Secondary Outcome Measures

Name	Time	Method
Impact of age	Before chemotherapy (baseline), end of chemotherapy and follow-up up to 12 months after chemotherapy	The secondary objective is to assess the impact of age on the extent of memory impairment.

Trial Locations

Locations (2)

Centre François BACLESSE; 🇫🇷 Caen, Calvados, France

Centre de recherche CYCERON; 🇫🇷 Caen, Calvados, France