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

This study is currently recruiting participants.
Verified May 2012 by Centre Francois Baclesse
Sponsor:
Information provided by:
Centre Francois Baclesse
ClinicalTrials.gov Identifier:
NCT01332916
First received: April 8, 2011
Last updated: May 31, 2012
Last verified: May 2012
  Purpose

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


Condition Intervention Phase
Breast Cancer
Healthy
Procedure: cognitive tests and cerebral IRM
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Impact of Cancer on Memory Functioning: Understanding Disorders Using Approaches in Neuropsychology and Neuroimaging

Resource links provided by NLM:


Further study details as provided by Centre Francois Baclesse:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • Impact of age [ Time Frame: Before chemotherapy (baseline), end of chemotherapy and follow-up up to 12 months after chemotherapy ] [ Designated as safety issue: No ]
    The secondary objective is to assess the impact of age on the extent of memory impairment.


Estimated Enrollment: 60
Study Start Date: December 2010
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: patients aged 45 and over group
patients aged 45 and over with breast cancer and should receive an adjuvant chemotherapy
Procedure: cognitive tests and cerebral IRM
cognitive tests and cerebral IRM
Active Comparator: healthy volunteers (controls) aged 45 and over
healthy volunteers (controls) aged 45 and over
Procedure: cognitive tests and cerebral IRM
cognitive tests and cerebral IRM

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01332916

Contacts
Contact: Florence JOLY-LOBBEDEZ, PD 0231455002 f.joly@baclesse.fr

Locations
France
Centre François BACLESSE Recruiting
Caen, Calvados, France, 14076
Contact: Florence JOLY-LOBBEDEZ, PD         
Principal Investigator: Florence JOLY-LOBBEDEZ, PD         
Sub-Investigator: Djelila ALLOUACHE, MD         
Sub-Investigator: Corinne DELCAMBRE, MD         
Sub-Investigator: Christelle LEVY, MD         
Sub-Investigator: Jean M OLLIVIER, MD         
Sub-Investigator: Carine SEGURA, MD         
Sub-Investigator: Odile SWITSERS, MD         
Sub-Investigator: Joëlle LACROIX, MD         
Centre de recherche CYCERON Recruiting
Caen, Calvados, France, 14076
Contact: Jacques DAYAN, MD         
Principal Investigator: Jacques DAYAN, MD         
Sub-Investigator: Françis EUSTACHE, PD         
Sub-Investigator: Bénédicte GIFFARD, MD         
Sub-Investigator: Vincent de la SAYETTE, MD         
Sub-Investigator: Laurence CARLUER, MD         
Sub-Investigator: Anne QUILLARD, MD         
Sub-Investigator: Fausto QUILLARD, MD         
Sub-Investigator: Christian SCHUPP, MD         
Sub-Investigator: Nathalie DERACHE, MD         
Sub-Investigator: Jean M CONSTANS, MD         
Sub-Investigator: Fabian GUENOLE, MD         
Sponsors and Collaborators
Centre Francois Baclesse
  More Information

No publications provided

Responsible Party: Pr Florence JOLY-LOBBEDEZ, Centre François Baclesse
ClinicalTrials.gov Identifier: NCT01332916     History of Changes
Other Study ID Numbers: CANMEM
Study First Received: April 8, 2011
Last Updated: May 31, 2012
Health Authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé

Keywords provided by Centre Francois Baclesse:
No metastatic breast cancer
cognitive troubles
adjuvant chemotherapy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on April 17, 2014