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

This study has been terminated.
(lack of patient)
Sponsor:
Information provided by:
Centre Francois Baclesse
ClinicalTrials.gov Identifier:
NCT01332916
First received: April 8, 2011
Last updated: April 24, 2014
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
Study Completion Date: April 2014
Primary Completion Date: December 2013 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01332916

Locations
France
Centre François BACLESSE
Caen, Calvados, France, 14076
Centre de recherche CYCERON
Caen, Calvados, France, 14076
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: April 24, 2014
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 July 24, 2014