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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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
        • Hôpitaux Universitaires
    • Calvados
      • Caen, Calvados, France, 14076
        • Centre François Baclesse
      • Caen, Calvados, France, 14033
        • CHU
      • Caen, Calvados, France, 14000
        • INSERM
    • Ile de France
      • Paris, Ile de France, France, 75475
        • Hôpital 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 Hôpital 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Francois Baclesse

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Sanofi
National Cancer Institute, France

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Florence JOLY-LOBBEDEZ, PD, Centre François 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 8, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 12, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 4, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 3, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings