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


Phase 2
45 Years
N/A
Open (Enrolling)
Female
Breast Cancer, Healthy

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Trial Information

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

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Outcome Measure:

Assess the relationship between memory impairment and brain dysfunction

Outcome Description:

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.

Outcome Time Frame:

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

Safety Issue:

No

Authority:

France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé

Study ID:

CANMEM

NCT ID:

NCT01332916

Start Date:

December 2010

Completion Date:

June 2018

Related Keywords:

  • Breast Cancer
  • Healthy
  • No metastatic breast cancer
  • cognitive troubles
  • adjuvant chemotherapy
  • Breast Neoplasms

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