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

Study Overview
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Brief Summary
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The purpose of this study is to investigate memory problems in patients with cancer.

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

Conditions
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Healthy, Breast Cancer

Intervention / Treatment
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* Procedure: cognitive tests and cerebral IRM
* Procedure: cognitive tests and cerebral IRM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria for patients: Patients aged 45 and over Patients from Grade 3 'end of primary schooling minimum (scale Barbizet) Non-Metastatic Breast Cancer Adjuvant Chemotherapy: FEC, including Docetaxel Protocols No major cognitive impairment No previous neurological Lack of personality disorders and psychiatric disorders evolutionary Having signed the informed consent of study participation Inclusion Criteria for control group: Women from the general population aged 45 and over, and matched in age and cultural level in patients Topics of Grade 3 'end of primary schooling minimum (scale Barbizet) No prior cancer No major cognitive impairment No previous neurological Lack of personality disorders and psychiatric disorders evolutionary Participating in the IMAP Protocol No. ID-BCR: 2007-A00414-49 or IMAP+(n° ID RCB 2011-A01493-38)(see how the study below) have signed forms no objection and consent to study participation 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

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: patients aged 45 and over group<br>patients aged 45 and over with breast cancer and should receive an adjuvant chemotherapy | Procedure: cognitive tests and cerebral IRM<br>* cognitive tests and cerebral IRM<br>|
| Active Comparator: healthy volunteers (controls) aged 45 and over<br>healthy volunteers (controls) aged 45 and over | Procedure: cognitive tests and cerebral IRM<br>* cognitive tests and cerebral IRM<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the relationship between memory impairment and brain dysfunction | 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. | Before chemotherapy (baseline), end of chemotherapy and follow-up up to 12 months after chemotherapy | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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No metastatic breast cancer, cognitive troubles, adjuvant chemotherapy