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

Completed

• Conditions: Breast Cancer

• Registration Number: NCT01333735
• Lead Sponsor: Centre Francois Baclesse

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2011-04-08
• Study First Submitted QC: 2011-04-11
• Study First Posted: 2011-04-12
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-03
• Last Update Posted: 2015-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 114

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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)
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
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

Trial Locations

Locations (13)

Université; 🇫🇷 Lille, Nord, France

Hopital TENON; 🇫🇷 Paris, Ile de France, France

INSERM; 🇫🇷 Caen, Calvados, France

CHU; 🇫🇷 Rouen, Seine Maritime, France

Hôpital Saint-Louis; 🇫🇷 Paris, Ile de France, France

CHRU Hôpital Claude Huriez; 🇫🇷 Lille, Nord, France

Centre François BACLESSE; 🇫🇷 Caen, Calvados, France

CHU, Hôpital Bois Guillaume; 🇫🇷 Rouen, Seine Maritime, France

Hopital Pitié-Sapètrière; 🇫🇷 Paris, Ile de France, France

Hopital gériatrique des Bateliers; 🇫🇷 Lille, Nord, France

Centre Henri BECQUEREL; 🇫🇷 Rouen, Seine Maritime, France

Hôpital Charles FOIX; 🇫🇷 IVRY sur SEINE, France

Hopitaux universitaires; 🇫🇷 Strasbourg, France