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

Healthy Clinical Trial

— CANMEM  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01332916
• Other study ID #: CANMEM
• Status: Terminated
• Phase: Phase 2
• First received: April 8, 2011
• Last updated: April 24, 2014
• Start date: December 2010
• Est. completion date: April 2014

Study information

• Verified date: May 2012
• Source: Centre Francois Baclesse
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 60
• Est. completion date: April 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Breast Cancer
• Healthy

Intervention

Procedure:
• cognitive tests and cerebral IRM
cognitive tests and cerebral IRM
• cognitive tests and cerebral IRM
cognitive tests and cerebral IRM

Locations

Country	Name	City	State
France	Centre de recherche CYCERON	Caen	Calvados
France	Centre François BACLESSE	Caen	Calvados

Sponsors (1)

Lead Sponsor	Collaborator
Centre Francois Baclesse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No