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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01333735

Acronym

COG AGE

Enrollment

114

Registered

2011-04-12

Start date

2008-12-31

Completion date

2015-07-31

Last updated

2015-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

cognitive functions, quality of life, breast cancer, chemotherapy, ages patients

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

66 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
impact of memory impairment	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

Secondary

Measure	Time frame	Description
Relationship between performance and onco-geriatric cognitive	Before chemotherapy (baseline), end of chemotherapy and follow-up up to 24 months after chemotherapy	Examine the relationship between performance and onco-geriatric cognitive
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	Studying the correlations between disorders of cognitive functions and parameters of quality of life
Biological disturbances	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
Impact of age	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
lived of the entourage	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)

Countries

Belgium, France

Outcome results