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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)

This study has been completed.
Sponsor:
Collaborators:
National Cancer Institute, France
Sanofi
Information provided by:
Centre Francois Baclesse
ClinicalTrials.gov Identifier:
NCT01333735
First received: April 8, 2011
Last updated: September 3, 2015
Last verified: September 2015
  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
Study Completion Date: July 2015
Primary Completion Date: July 2015 (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   (Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01333735

Locations
Belgium
Université
Bruxelles, Belgium, 1050
France
INSERM
Caen, Calvados, France, 14000
CHU
Caen, Calvados, France, 14033
Centre François BACLESSE
Caen, Calvados, France, 14076
Hôpital Saint-Louis
Paris, Ile de France, France, 75475
Hopital Pitié-Sapètrière
Paris, Ile de France, France, 75651
Hopital TENON
Paris, Ile de France, France, 75970
CHRU Hôpital Claude Huriez
Lille, Nord, France, 59000
Hopital gériatrique des Bateliers
Lille, Nord, France, 59037
Université
Lille, Nord, France, 59653
CHU, Hôpital Bois Guillaume
Rouen, Seine Maritime, France, 76000
CHU
Rouen, Seine Maritime, France, 76000
Centre Henri BECQUEREL
Rouen, Seine Maritime, France, 76038
Hôpital Charles FOIX
IVRY sur SEINE, France, 94206
Hopitaux universitaires
Strasbourg, France, 67091
Sponsors and Collaborators
Centre Francois Baclesse
National Cancer Institute, France
Sanofi
Investigators
Principal Investigator: Florence JOLY-LOBBEDEZ, PD Centre François Baclesse
  More Information

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: September 3, 2015
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 September 27, 2016