Impact of Cancer on Memory Functioning: Understanding Disorders Using Approaches in Neuropsychology and Neuroimaging (CANMEM)
This study is currently recruiting participants.
Verified May 2012 by Centre Francois Baclesse
Sponsor:
Centre Francois Baclesse
Information provided by:
Centre Francois Baclesse
ClinicalTrials.gov Identifier:
NCT01332916
First received: April 8, 2011
Last updated: May 31, 2012
Last verified: May 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
| Estimated Study Completion Date: | June 2018 |
| Estimated Primary Completion Date: | December 2016 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01332916
Contacts
| Contact: Florence JOLY-LOBBEDEZ, PD | 0231455002 | f.joly@baclesse.fr |
Locations
| France | |
| Centre François BACLESSE | Recruiting |
| Caen, Calvados, France, 14076 | |
| Contact: Florence JOLY-LOBBEDEZ, PD | |
| Principal Investigator: Florence JOLY-LOBBEDEZ, PD | |
| Sub-Investigator: Djelila ALLOUACHE, MD | |
| Sub-Investigator: Corinne DELCAMBRE, MD | |
| Sub-Investigator: Christelle LEVY, MD | |
| Sub-Investigator: Jean M OLLIVIER, MD | |
| Sub-Investigator: Carine SEGURA, MD | |
| Sub-Investigator: Odile SWITSERS, MD | |
| Sub-Investigator: Joëlle LACROIX, MD | |
| Centre de recherche CYCERON | Recruiting |
| Caen, Calvados, France, 14076 | |
| Contact: Jacques DAYAN, MD | |
| Principal Investigator: Jacques DAYAN, MD | |
| Sub-Investigator: Françis EUSTACHE, PD | |
| Sub-Investigator: Bénédicte GIFFARD, MD | |
| Sub-Investigator: Vincent de la SAYETTE, MD | |
| Sub-Investigator: Laurence CARLUER, MD | |
| Sub-Investigator: Anne QUILLARD, MD | |
| Sub-Investigator: Fausto QUILLARD, MD | |
| Sub-Investigator: Christian SCHUPP, MD | |
| Sub-Investigator: Nathalie DERACHE, MD | |
| Sub-Investigator: Jean M CONSTANS, MD | |
| Sub-Investigator: Fabian GUENOLE, MD | |
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: | May 31, 2012 |
| 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 June 18, 2013