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

This study has been terminated.
(lack of patient)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01332916
First Posted: April 11, 2011
Last Update Posted: April 25, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Centre Francois Baclesse
  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: None (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 ]
    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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01332916


Locations
France
Centre de recherche CYCERON
Caen, Calvados, France, 14076
Centre François BACLESSE
Caen, Calvados, France, 14076
Sponsors and Collaborators
Centre Francois Baclesse
  More Information

Responsible Party: Pr Florence JOLY-LOBBEDEZ, Centre François Baclesse
ClinicalTrials.gov Identifier: NCT01332916     History of Changes
Other Study ID Numbers: CANMEM
First Submitted: April 8, 2011
First Posted: April 11, 2011
Last Update Posted: April 25, 2014
Last Verified: May 2012

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