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

NCT01333735 | Completed

• 1 other identifier: COG AGE
• Study Type: observational
• Target: 114
• Locations: 2 countries
• Sites: 15

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.

Conditions

Breast Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

  Before chemotherapy (baseline), end of chemotherapy and follow-up up to 24 months after chemotherapy

• Biological disturbances

  Before chemotherapy (baseline), end of chemotherapy and follow-up up to 24 months after chemotherapy

• Impact of age

  Before chemotherapy (baseline), end of chemotherapy and follow-up up to 24 months after chemotherapy

• lived of the entourage

  Before chemotherapy (baseline), end of chemotherapy and follow-up up to 12 months after chemotherapy

Study Arms (2)

Patients with chemotherapy group

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

Patients without chemotherapy group

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

Eligibility Criteria

• Age: 66 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients with chemotherapy group and patients without chemotherapy group (control group)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Francois Baclesse: lead
• National Cancer Institute, France: collaborator
• Sanofi: collaborator

Study Sites (15)

Université

Brussels, 1050, Belgium

Location

INSERM

Caen, Calvados, 14000, France

Location

CHU

Caen, Calvados, 14033, France

Location

Centre François BACLESSE

Caen, Calvados, 14076, France

Location

CHRU Hôpital Claude Huriez

Lille, Nord, 59000, France

Location

Hopital gériatrique des Bateliers

Lille, Nord, 59037, France

Location

Université

Lille, Nord, 59653, France

Location

CHU, Hôpital Bois Guillaume

Rouen, Seine Maritime, 76000, France

Location

CHU

Rouen, Seine Maritime, 76000, France

Location

Centre Henri BECQUEREL

Rouen, Seine Maritime, 76038, France

Location

Hôpital Charles FOIX

Ivry-sur-Seine, 94206, France

Location

Hopitaux universitaires

Strasbourg, 67091, France

Location

Hôpital Saint-Louis

Paris, Île-de-France Region, 75475, France

Location

Hopital Pitié-Sapètrière

Paris, Île-de-France Region, 75651, France

Location

Hopital TENON

Paris, Île-de-France Region, 75970, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

NFS, uree, creatinin, ASAT, ALAT, PAL, GGT, Vit D, B12, Folates, Albumin, lipid, TSH, testosteron, oestradiol, LH, FSH, TP, TCA, D-Dimeres, Homocystéine, plasmatic biomarkers(protein S100, NSE, CRP, IL6)

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Florence JOLY-LOBBEDEZ, PD

  Centre François Baclesse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 8, 2011
• First Posted: April 12, 2011
• Study Start: December 1, 2008
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: September 4, 2015

Record last verified: 2015-09

Locations

BE (1); FR (14)