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

Study Overview
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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.

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

Conditions
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Breast Cancer

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 66 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with chemotherapy group<br>Patients with breast or colon cancer must beginning a chemotherapy (colon group was ended) | |
| Patients without chemotherapy group<br>patient with breast or colon cancer should not receive chemotherapy (colon group was ended) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| impact of memory impairment | 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| correlations between disorders of cognitive functions and parameters of quality of life | 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 | 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 | 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 | 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 | - 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cognitive functions, quality of life, breast cancer, chemotherapy, ages patients