CClinicalTrials.gg
Sign In
TerminatedNCT01332916CANMEMUpdated Apr 25, 2014

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

A Phase 2 interventional study of cognitive tests and cerebral IRM and cognitive tests and cerebral IRM in Breast Cancer and Healthy, sponsored by Centre Francois Baclesse. Terminated at 2 sites in France. Open to female participants aged 45 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-04-25.

Sponsored by Centre Francois Baclesse · Phase 2 and Interventional

Why this study was terminated
lack of patient
Phase
Phase 2
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
45 Years and older
Sex
Female
01

Study summary

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

02

Conditions studied

  • Breast Cancer
  • Healthy

Browse trials for

Keywords

  • No metastatic breast cancer
  • cognitive troubles
  • adjuvant chemotherapy
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 60 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Centre Francois Baclesse is the lead sponsor of 109 studies on the registry; 26 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Eligibility 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
05

Study design

Phase
Phase 2
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • 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

  • Active comparator
    healthy volunteers (controls) aged 45 and over

    healthy volunteers (controls) aged 45 and over

    Procedure: cognitive tests and cerebral IRM

Interventions

  • Procedurecognitive tests and cerebral IRM

    cognitive tests and cerebral IRM

  • Procedurecognitive tests and cerebral IRM

    cognitive tests and cerebral IRM

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Before chemotherapy (baseline), end of chemotherapy and follow-up up to 12 months after chemotherapy

Secondary outcomes

  1. Impact of age

    The secondary objective is to assess the impact of age on the extent of memory impairment.

    Time frame: Before chemotherapy (baseline), end of chemotherapy and follow-up up to 12 months after chemotherapy

07

Study locations

2 sites
  • Centre de recherche CYCERON
    Caen, Calvados 14076, France
  • Centre François BACLESSE
    Caen, Calvados 14076, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 25, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01332916
Lead sponsor
Centre Francois Baclesse
First posted
Apr 11, 2011
Start date
Dec 2010
Primary completion
Dec 2013
Completion
Apr 2014
Last update
Apr 25, 2014

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in May 2012. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Breast Neoplasms→

Other studies from this sponsor

Centre Francois Baclesse

Start the discussion