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

April 24, 2014 updated by: Centre Francois Baclesse
The purpose of this study is to investigate memory problems in patients with cancer.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Calvados
      • Caen, Calvados, France, 14076
        • Centre François Baclesse
      • Caen, Calvados, France, 14076
        • Centre de recherche CYCERON

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Procedure: cognitive tests and cerebral IRM
cognitive tests and cerebral IRM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Before chemotherapy (baseline), end of chemotherapy and follow-up up to 12 months after chemotherapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Before chemotherapy (baseline), end of chemotherapy and follow-up up to 12 months after chemotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Francois Baclesse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

April 8, 2011

First Submitted That Met QC Criteria

April 8, 2011

First Posted (Estimate)

April 11, 2011

Study Record Updates

Last Update Posted (Estimate)

April 25, 2014

Last Update Submitted That Met QC Criteria

April 24, 2014

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CANMEM

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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