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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01332916
• Date of registration: 08/04/2011
• Prospective Registration: No
• Primary sponsor: Centre Francois Baclesse
• Public title: Impact of Cancer on Memory Functioning: Understanding Disorders Using Approaches in Neuropsychology and Neuroimaging CANMEM
• Scientific title: Impact of Cancer on Memory Functioning: Understanding Disorders Using Approaches in Neuropsychology and Neuroimaging
• Date of first enrolment: December 2010
• Target sample size: 60
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT01332916
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
• Phase: Phase 2

Countries of recruitment

France

Key inclusion & exclusion criteria

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



Age minimum: 45 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Breast Cancer

Healthy

Intervention(s)

Procedure: cognitive tests and cerebral IRM

Primary Outcome(s)

Assess the relationship between memory impairment and brain dysfunction [Time Frame: Before chemotherapy (baseline), end of chemotherapy and follow-up up to 12 months after chemotherapy]

Secondary Outcome(s)

Impact of age [Time Frame: Before chemotherapy (baseline), end of chemotherapy and follow-up up to 12 months after chemotherapy]

Secondary ID(s)

CANMEM

Source(s) of Monetary Support

Please refer to primary and secondary sponsors