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

Breast Cancer Clinical Trial

— COG AGE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01333735
• Other study ID #: COG AGE
• Status: Completed
• Phase: N/A
• First received: April 8, 2011
• Last updated: September 3, 2015
• Start date: December 2008
• Est. completion date: July 2015

Study information

• Verified date: September 2015
• Source: Centre Francois Baclesse
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 66 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
Belgium	Université	Bruxelles
France	Centre François BACLESSE	Caen	Calvados
France	CHU	Caen	Calvados
France	INSERM	Caen	Calvados
France	Hôpital Charles FOIX	IVRY sur SEINE
France	CHRU Hôpital Claude Huriez	Lille	Nord
France	Hopital gériatrique des Bateliers	Lille	Nord
France	Université	Lille	Nord
France	Hopital Pitié-Sapètrière	Paris	Ile de France
France	Hôpital Saint-Louis	Paris	Ile de France
France	Hopital TENON	Paris	Ile de France
France	Centre Henri BECQUEREL	Rouen	Seine Maritime
France	CHU	Rouen	Seine Maritime
France	CHU, Hôpital Bois Guillaume	Rouen	Seine Maritime
France	Hopitaux universitaires	Strasbourg

Sponsors (3)

Lead Sponsor	Collaborator
Centre Francois Baclesse	National Cancer Institute, France, Sanofi

Countries where clinical trial is conducted

Belgium,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No