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

Centre Francois Baclesse

Status: Completed

Conditions: Breast Cancer

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01333735

COG AGE

Details and patient eligibility

About

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.

Enrollment: 114 estimated patients

Sex: Female

Ages: 66+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

114 participants in 2 patient groups

Patients with chemotherapy group

Description:

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

Patients without chemotherapy group

Description:

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