Impact on Cognitive Function and Quality of Life of Adjuvant Chemotherapy in Patients Aged Over 65 Years: Application to Breast Cancer or Colon (COG AGE)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Centre Francois Baclesse.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
National Cancer Institute, France
Sanofi
Information provided by:
Centre Francois Baclesse
ClinicalTrials.gov Identifier:
NCT01333735
First received: April 8, 2011
Last updated: December 19, 2011
Last verified: December 2011
  Purpose

The aim of the study is to investigate the impact of adjuvant chemotherapy on cognitive function in patients aged over 65 and suffering from breast cancer or colon.


Condition
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact on Cognitive Function and Quality of Life of Adjuvant Chemotherapy in Patients Aged Over 65 Years: Application to Breast Cancer or Colon

Resource links provided by NLM:


Further study details as provided by Centre Francois Baclesse:

Primary Outcome Measures:
  • impact of memory impairment [ Time Frame: Before chemotherapy (baseline), end of chemotherapy and follow-up up to 24 months after chemotherapy ] [ Designated as safety issue: No ]

    Assessing the impact of memory impairment induced by chemotherapy and study their evolution over time, with patients over 65 years treated in the adjuvant setting for breast cancer.

    Evaluated by auto-questionnary an tests with a neuropsychologist



Secondary Outcome Measures:
  • correlations between disorders of cognitive functions and parameters of quality of life [ Time Frame: Before chemotherapy (baseline), end of chemotherapy and follow-up up to 24 months after chemotherapy ] [ Designated as safety issue: No ]
    Studying the correlations between disorders of cognitive functions and parameters of quality of life

  • Relationship between performance and onco-geriatric cognitive [ Time Frame: Before chemotherapy (baseline), end of chemotherapy and follow-up up to 24 months after chemotherapy ] [ Designated as safety issue: No ]
    Examine the relationship between performance and onco-geriatric cognitive

  • Biological disturbances [ Time Frame: Before chemotherapy (baseline), end of chemotherapy and follow-up up to 24 months after chemotherapy ] [ Designated as safety issue: No ]
    Search for biological disturbances may be related to cognitive impairment observed

  • Impact of age [ Time Frame: Before chemotherapy (baseline), end of chemotherapy and follow-up up to 24 months after chemotherapy ] [ Designated as safety issue: No ]
    Assess the impact of age on the magnitude of cognitive impairment in patients

  • lived of the entourage [ Time Frame: Before chemotherapy (baseline), end of chemotherapy and follow-up up to 12 months after chemotherapy ] [ Designated as safety issue: No ]
    - Assess the impact and cognitive impairment of patients'experiences of the circle (translational research)


Biospecimen Retention:   Samples Without DNA

NFS, uree, creatinin, ASAT, ALAT, PAL, GGT, Vit D, B12, Folates, Albumin, lipid, TSH, testosteron, oestradiol, LH, FSH, TP, TCA, D-Dimeres, Homocystéine, plasmatic biomarkers(protein S100, NSE, CRP, IL6)


Estimated Enrollment: 114
Study Start Date: December 2008
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients with chemotherapy group
Patients with breast or colon cancer must beginning a chemotherapy (colon group was ended)
Patients without chemotherapy group
patient with breast or colon cancer should not receive chemotherapy (colon group was ended)

  Eligibility

Ages Eligible for Study:   66 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

patients with chemotherapy group and patients without chemotherapy group (control group)

Criteria

Inclusion Criteria for patients with chemotherapy :

  • Patient(e) aged over 65 years
  • Non metastatic breast cancer
  • Adjuvant chemotherapy Breast cancer: FEC, including Docetaxel Protocols
  • No major cognitive impairment
  • Lack of personality disorders and psychiatric disorders evolutionary
  • Having signed the informed consent of study participation

Inclusion Criteria for patients without chemotherapy (control group):

  • Patient(e) aged over 65 years
  • Breast cancer
  • Patients receiving no adjuvant chemotherapy
  • No major cognitive impairment
  • Lack of personality disorders and psychiatric disorders evolutionary
  • Having signed the informed consent of study participation
  • Matching on age, sex, cultural level and tumor location

Exclusion Criteria for patients with chemotherapy :

  • Metastatic
  • Cancer primitive other than breast
  • Patients under 65 years
  • Patients with adjuvant chemotherapy is associated with targeted therapy
  • Patients who have received other cancer treatments (chemotherapy or radiotherapy brain)
  • disorders of higher functions existing in the administration of chemotherapy
  • 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: NCT01333735

Contacts
Contact: Florence JOLY-LOBBEDEZ, PD 02 31 45 50 02 f.joly@baclesse.fr

Locations
Belgium
Université Recruiting
Bruxelles, Belgium, 1050
Contact: Darius RAZAVI, PD         
Principal Investigator: Darius RAZAVI, PD         
France
INSERM Recruiting
Caen, Calvados, France, 14000
Contact: Francis EUSTACHE, PD         
Principal Investigator: Françis EUSTACHE, PD         
CHU Recruiting
Caen, Calvados, France, 14033
Contact: Karine BOUHIER-LEPORRIER, MD         
Principal Investigator: Karine BOUHIER-LEPORRIER, MD         
Sub-Investigator: Marie P GALAIS, MD         
Sub-Investigator: ARSENE, MD         
Centre François BACLESSE Recruiting
Caen, Calvados, France, 14076
Contact: Florence JOLY-LOBBEDEZ, PD    02 31 45 50 02    f.joly@baclesse.fr   
Principal Investigator: Florence JOLY-LOBBEDEZ, PD         
Sub-Investigator: Christelle LEVY, MD         
Sub-Investigator: Emmanuel SEVIN, MD         
Sub-Investigator: Jean M OLLIVIER, MD         
Sub-Investigator: Jacques H JACOB, MD         
Sub-Investigator: Jean M GUILLOIT, MD         
Sub-Investigator: Che M M'VONDO, MD         
Sub-Investigator: Marie P GALAIS, MD         
Sub-Investigator: Carine SEGURA, MD         
Sub-Investigator: Djelila ALLOUACHE, MD         
Sub-Investigator: Odile SWITSERS, MD         
Sub-Investigator: Corinne DELCAMBRE, MD         
Hopital Pitié-Sapètrière Recruiting
Paris, Ile de France, France, 75651
Contact: Jean P SPANO, PD         
Principal Investigator: Jean P SPANO, PD         
Sub-Investigator: Marc VERNY, PD         
Hôpital Saint-Louis Recruiting
Paris, Ile de France, France, 75475
Contact: Marc ESPIE, MD         
Principal Investigator: Marc ESPIE, MD         
Sub-Investigator: Naïma BEDAIRIA, MD         
Sub-Investigator: Caroline CUVIER, MD         
Sub-Investigator: Sylvie GIACCHETTI, MD         
Sub-Investigator: Abdelhamid HOCINI, MD         
Hopital TENON Recruiting
Paris, Ile de France, France, 75970
Contact: Daniel AVENIN, MD         
Principal Investigator: Daniel AVENIN, MD         
Sub-Investigator: Joseph GLIGOROV, MD         
Hopital gériatrique des Bateliers Recruiting
Lille, Nord, France, 59037
Contact: François PUISIEUX, PD         
Principal Investigator: François PUISIEUX, PD         
CHRU Hôpital Claude Huriez Recruiting
Lille, Nord, France, 59000
Contact: Mohamed HEBBAR, PD         
Principal Investigator: Mohamed HEBBAR, PD         
Sub-Investigator: Olivier ROMANO, MD         
Université Recruiting
Lille, Nord, France, 59653
Contact: Véronique CHRISTOPHE, MD         
Principal Investigator: Véronique CHRISTOPHE, MD         
Centre Henri BECQUEREL Recruiting
Rouen, Seine Maritime, France, 76038
Contact: Olivier RIGAL, MD         
Principal Investigator: Olivier RIGAL, MD         
Sub-Investigator: Corinne VEYRET, MD         
Sub-Investigator: Isabelle TENNEVET, MD         
Sub-Investigator: Marianne LEHEURTEUR, MD         
Sub-Investigator: Cécile GUILLEMET, MD         
Sub-Investigator: Annie CHEVRIER, MD         
Sub-Investigator: Emmanuel BLOT, MD         
CHU Recruiting
Rouen, Seine Maritime, France, 76000
Contact: Pierre MICHEL, PD         
Principal Investigator: Pierre MICHEL, PD         
Sub-Investigator: Frédéric DI FIORE, MD         
Sub-Investigator: David TOUGERON, MD         
Sub-Investigator: Bernard PAILLOT, MD         
Sub-Investigator: Isabelle IWANICKI-CARON, MD         
CHU, Hôpital Bois Guillaume Recruiting
Rouen, Seine Maritime, France, 76000
Contact: Philippe CHASSAGNE, MD         
Principal Investigator: Philippe CHASSAGNE, MD         
Hôpital Charles FOIX Recruiting
IVRY sur SEINE, France, 94206
Contact: François PIETTE, PD         
Principal Investigator: François PIETTE, PD         
Sub-Investigator: Pascal CHAIBI, MD         
Sub-Investigator: Amale CHEBIB, MD         
Hopitaux universitaires Recruiting
Strasbourg, France, 67091
Contact: Jean E KURTZ, PD         
Principal Investigator: Jean E Kurtz, PD         
Sub-Investigator: Fréderic BLANC, MD         
Sub-Investigator: Valère LITIQUE, MD         
Sub-Investigator: Sebastian SERRA, MD         
Sub-Investigator: Philippe BARTHELEMY, MD         
Sub-Investigator: Serge ROHR         
Sub-Investigator: Céline BRIGAND, MD         
Sub-Investigator: Carole MATHELIN, MD         
Sub-Investigator: Didier MUTTER, PD         
Sponsors and Collaborators
Centre Francois Baclesse
National Cancer Institute, France
Sanofi
Investigators
Principal Investigator: Florence JOLY-LOBBEDEZ, PD Centre François Baclesse
  More Information

No publications provided

Responsible Party: Pr Florence JOLY-LOBBEDEZ, Centre François Baclesse
ClinicalTrials.gov Identifier: NCT01333735     History of Changes
Other Study ID Numbers: COG AGE
Study First Received: April 8, 2011
Last Updated: December 19, 2011
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:
cognitive functions
quality of life
breast cancer
chemotherapy
ages patients

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on April 16, 2014