Clinical trial NCT01333735: Impact on Cognitive Function and Quality of Life of Adjuvant Chemotherapy in Patients Aged Over 65 Years: Application to Breast Cancer or Colon
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: cognitive functions
quality of life
breast cancer
chemotherapy
ages patients
Lead sponsor: Centre Francois Baclesse
Sponsor class: OTHER
Collaborators: name: National Cancer Institute, France
name: Sanofi
First posted: 2011-04-12
Enrollment: 114
Sex: FEMALE
Minimum age (years): 66
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with chemotherapy group and patients without chemotherapy group (control group)

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: impact of memory impairment
timeFrame: Before chemotherapy (baseline), end of chemotherapy and follow-up up to 24 months after chemotherapy
Secondary outcomes:
measure: correlations between disorders of cognitive functions and parameters of quality of life
timeFrame: Before chemotherapy (baseline), end of chemotherapy and follow-up up to 24 months after chemotherapy
measure: Relationship between performance and onco-geriatric cognitive
timeFrame: Before chemotherapy (baseline), end of chemotherapy and follow-up up to 24 months after chemotherapy
measure: Biological disturbances
timeFrame: Before chemotherapy (baseline), end of chemotherapy and follow-up up to 24 months after chemotherapy
measure: Impact of age
timeFrame: Before chemotherapy (baseline), end of chemotherapy and follow-up up to 24 months after chemotherapy
measure: lived of the entourage
timeFrame: Before chemotherapy (baseline), end of chemotherapy and follow-up up to 12 months after chemotherapy
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Université
city: Caen
country: France
facility: INSERM
state: Calvados
city: Caen
country: France
facility: CHU
state: Calvados
city: Caen
country: France
facility: Centre François BACLESSE
state: Calvados
city: Paris
country: France
facility: Hôpital Saint-Louis
state: Ile de France
city: Paris
country: France
facility: Hopital Pitié-Sapètrière
state: Ile de France
city: Paris
country: France
facility: Hopital TENON
state: Ile de France
city: Lille
country: France
facility: CHRU Hôpital Claude Huriez
state: Nord
city: Lille
country: France
facility: Hopital gériatrique des Bateliers
state: Nord
city: Lille
country: France
facility: Université
state: Nord
city: Rouen
country: France
facility: CHU, Hôpital Bois Guillaume
state: Seine Maritime
city: Rouen
country: France
facility: CHU
state: Seine Maritime
city: Rouen
country: France
facility: Centre Henri BECQUEREL
state: Seine Maritime
city: IVRY sur SEINE
country: France
facility: Hôpital Charles FOIX
city: Strasbourg
country: France
facility: Hopitaux universitaires
Study officials:
affiliation: Centre François Baclesse
name: Florence JOLY-LOBBEDEZ, PD
role: PRINCIPAL_INVESTIGATOR
References: