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

NCT ID: NCT01333735

Last Updated: 2015-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

114 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-12-31

Study Completion Date

2015-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with chemotherapy group

Patients with breast or colon cancer must beginning a chemotherapy (colon group was ended)

No interventions assigned to this group

Patients without chemotherapy group

patient with breast or colon cancer should not receive chemotherapy (colon group was ended)

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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


* 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

* 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
Minimum Eligible Age

66 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute, France

OTHER_GOV

Sponsor Role collaborator

Sanofi

INDUSTRY

Sponsor Role collaborator

Centre Francois Baclesse

OTHER

Sponsor Role lead

Responsible Party

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Centre François Baclesse

Principal Investigators

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Florence JOLY-LOBBEDEZ, PD

Role: PRINCIPAL_INVESTIGATOR

Centre François Baclesse

Locations

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Université

Brussels, , Belgium

Site Status

INSERM

Caen, Calvados, France

Site Status

CHU

Caen, Calvados, France

Site Status

Centre François BACLESSE

Caen, Calvados, France

Site Status

CHRU Hôpital Claude Huriez

Lille, Nord, France

Site Status

Hopital gériatrique des Bateliers

Lille, Nord, France

Site Status

Université

Lille, Nord, France

Site Status

CHU, Hôpital Bois Guillaume

Rouen, Seine Maritime, France

Site Status

CHU

Rouen, Seine Maritime, France

Site Status

Centre Henri BECQUEREL

Rouen, Seine Maritime, France

Site Status

Hôpital Charles FOIX

Ivry-sur-Seine, , France

Site Status

Hopitaux universitaires

Strasbourg, , France

Site Status

Hôpital Saint-Louis

Paris, Île-de-France Region, France

Site Status

Hopital Pitié-Sapètrière

Paris, Île-de-France Region, France

Site Status

Hopital TENON

Paris, Île-de-France Region, France

Site Status

Countries

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Belgium France

Other Identifiers

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COG AGE

Identifier Type: -

Identifier Source: org_study_id

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