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)

September 3, 2015 updated by: Centre Francois Baclesse
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Anticipated)

114

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Bruxelles, Belgium, 1050
        • Université
  • France
      • IVRY sur SEINE, France, 94206
        • Hôpital Charles Foix
      • Strasbourg, France, 67091
        • Hopitaux Universitaires
    • Calvados
      • Caen, Calvados, France, 14076
        • Centre Francois Baclesse
      • Caen, Calvados, France, 14033
        • CHU
      • Caen, Calvados, France, 14000
        • Inserm
    • Ile de France
      • Paris, Ile de France, France, 75475
        • Hopital Saint-Louis
      • Paris, Ile de France, France, 75651
        • Hopital Pitié-Sapètrière
      • Paris, Ile de France, France, 75970
        • Hôpital Tenon
    • Nord
      • Lille, Nord, France, 59000
        • CHRU Hopital Claude Huriez
      • Lille, Nord, France, 59037
        • Hopital gériatrique des Bateliers
      • Lille, Nord, France, 59653
        • Université
    • Seine Maritime
      • Rouen, Seine Maritime, France, 76038
        • Centre Henri Becquerel
      • Rouen, Seine Maritime, France, 76000
        • CHU, Hôpital Bois Guillaume
      • Rouen, Seine Maritime, France, 76000
        • CHU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

66 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
impact of memory impairment
Time Frame: Before chemotherapy (baseline), end of chemotherapy and follow-up up to 24 months after chemotherapy

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
Before chemotherapy (baseline), end of chemotherapy and follow-up up to 24 months after chemotherapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Studying the correlations between disorders of cognitive functions and parameters of quality of life
Before chemotherapy (baseline), end of chemotherapy and follow-up up to 24 months after chemotherapy
Relationship between performance and onco-geriatric cognitive
Time Frame: Before chemotherapy (baseline), end of chemotherapy and follow-up up to 24 months after chemotherapy
Examine the relationship between performance and onco-geriatric cognitive
Before chemotherapy (baseline), end of chemotherapy and follow-up up to 24 months after chemotherapy
Biological disturbances
Time Frame: Before chemotherapy (baseline), end of chemotherapy and follow-up up to 24 months after chemotherapy
Search for biological disturbances may be related to cognitive impairment observed
Before chemotherapy (baseline), end of chemotherapy and follow-up up to 24 months after chemotherapy
Impact of age
Time Frame: Before chemotherapy (baseline), end of chemotherapy and follow-up up to 24 months after chemotherapy
Assess the impact of age on the magnitude of cognitive impairment in patients
Before chemotherapy (baseline), end of chemotherapy and follow-up up to 24 months after chemotherapy
lived of the entourage
Time Frame: Before chemotherapy (baseline), end of chemotherapy and follow-up up to 12 months after chemotherapy
- Assess the impact and cognitive impairment of patients'experiences of the circle (translational research)
Before chemotherapy (baseline), end of chemotherapy and follow-up up to 12 months after chemotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Francois Baclesse

Collaborators

Sanofi
National Cancer Institute, France

Investigators

  • Principal Investigator: Florence JOLY-LOBBEDEZ, PD, Centre Francois Baclesse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

April 8, 2011

First Submitted That Met QC Criteria

April 11, 2011

First Posted (Estimate)

April 12, 2011

Study Record Updates

Last Update Posted (Estimate)

September 4, 2015

Last Update Submitted That Met QC Criteria

September 3, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COG AGE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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