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
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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COMPLETED
114 participants
OBSERVATIONAL
2008-12-31
2015-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
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
* 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
* 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
66 Years
FEMALE
No
Sponsors
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National Cancer Institute, France
OTHER_GOV
Sanofi
INDUSTRY
Centre Francois Baclesse
OTHER
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
INSERM
Caen, Calvados, France
CHU
Caen, Calvados, France
Centre François BACLESSE
Caen, Calvados, France
CHRU Hôpital Claude Huriez
Lille, Nord, France
Hopital gériatrique des Bateliers
Lille, Nord, France
Université
Lille, Nord, France
CHU, Hôpital Bois Guillaume
Rouen, Seine Maritime, France
CHU
Rouen, Seine Maritime, France
Centre Henri BECQUEREL
Rouen, Seine Maritime, France
Hôpital Charles FOIX
Ivry-sur-Seine, , France
Hopitaux universitaires
Strasbourg, , France
Hôpital Saint-Louis
Paris, Île-de-France Region, France
Hopital Pitié-Sapètrière
Paris, Île-de-France Region, France
Hopital TENON
Paris, Île-de-France Region, France
Countries
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Other Identifiers
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COG AGE
Identifier Type: -
Identifier Source: org_study_id
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