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)
This study is currently recruiting participants.
Verified December 2011 by Centre Francois Baclesse
Sponsor:
Centre Francois Baclesse
Collaborators:
National Cancer Institute, France
Sanofi
Information provided by:
Centre Francois Baclesse
ClinicalTrials.gov Identifier:
NCT01333735
First received: April 8, 2011
Last updated: December 19, 2011
Last verified: December 2011
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Purpose
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.
| Condition |
|---|
|
Breast Cancer |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| 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 |
Resource links provided by NLM:
Further study details as provided by Centre Francois Baclesse:
Primary Outcome Measures:
- impact of memory impairment [ Time Frame: Before chemotherapy (baseline), end of chemotherapy and follow-up up to 24 months after chemotherapy ] [ Designated as safety issue: No ]
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:
- correlations between disorders of cognitive functions and parameters of quality of life [ Time Frame: Before chemotherapy (baseline), end of chemotherapy and follow-up up to 24 months after chemotherapy ] [ Designated as safety issue: No ]Studying the correlations between disorders of cognitive functions and parameters of quality of life
- Relationship between performance and onco-geriatric cognitive [ Time Frame: Before chemotherapy (baseline), end of chemotherapy and follow-up up to 24 months after chemotherapy ] [ Designated as safety issue: No ]Examine the relationship between performance and onco-geriatric cognitive
- Biological disturbances [ Time Frame: Before chemotherapy (baseline), end of chemotherapy and follow-up up to 24 months after chemotherapy ] [ Designated as safety issue: No ]Search for biological disturbances may be related to cognitive impairment observed
- Impact of age [ Time Frame: Before chemotherapy (baseline), end of chemotherapy and follow-up up to 24 months after chemotherapy ] [ Designated as safety issue: No ]Assess the impact of age on the magnitude of cognitive impairment in patients
- lived of the entourage [ Time Frame: Before chemotherapy (baseline), end of chemotherapy and follow-up up to 12 months after chemotherapy ] [ Designated as safety issue: No ]- Assess the impact and cognitive impairment of patients'experiences of the circle (translational research)
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)
| Estimated Enrollment: | 114 |
| Study Start Date: | December 2008 |
| Estimated Study Completion Date: | January 2013 |
| Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
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| Ages Eligible for Study: | 66 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
patients with chemotherapy group and patients without chemotherapy group (control group)
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01333735
Contacts
| Contact: Florence JOLY-LOBBEDEZ, PD | 02 31 45 50 02 | f.joly@baclesse.fr |
Locations
| Belgium | |
| Université | Recruiting |
| Bruxelles, Belgium, 1050 | |
| Contact: Darius RAZAVI, PD | |
| Principal Investigator: Darius RAZAVI, PD | |
| France | |
| INSERM | Recruiting |
| Caen, Calvados, France, 14000 | |
| Contact: Francis EUSTACHE, PD | |
| Principal Investigator: Françis EUSTACHE, PD | |
| CHU | Recruiting |
| Caen, Calvados, France, 14033 | |
| Contact: Karine BOUHIER-LEPORRIER, MD | |
| Principal Investigator: Karine BOUHIER-LEPORRIER, MD | |
| Sub-Investigator: Marie P GALAIS, MD | |
| Sub-Investigator: ARSENE, MD | |
| Centre François BACLESSE | Recruiting |
| Caen, Calvados, France, 14076 | |
| Contact: Florence JOLY-LOBBEDEZ, PD 02 31 45 50 02 f.joly@baclesse.fr | |
| Principal Investigator: Florence JOLY-LOBBEDEZ, PD | |
| Sub-Investigator: Christelle LEVY, MD | |
| Sub-Investigator: Emmanuel SEVIN, MD | |
| Sub-Investigator: Jean M OLLIVIER, MD | |
| Sub-Investigator: Jacques H JACOB, MD | |
| Sub-Investigator: Jean M GUILLOIT, MD | |
| Sub-Investigator: Che M M'VONDO, MD | |
| Sub-Investigator: Marie P GALAIS, MD | |
| Sub-Investigator: Carine SEGURA, MD | |
| Sub-Investigator: Djelila ALLOUACHE, MD | |
| Sub-Investigator: Odile SWITSERS, MD | |
| Sub-Investigator: Corinne DELCAMBRE, MD | |
| Hopital Pitié-Sapètrière | Recruiting |
| Paris, Ile de France, France, 75651 | |
| Contact: Jean P SPANO, PD | |
| Principal Investigator: Jean P SPANO, PD | |
| Sub-Investigator: Marc VERNY, PD | |
| Hôpital Saint-Louis | Recruiting |
| Paris, Ile de France, France, 75475 | |
| Contact: Marc ESPIE, MD | |
| Principal Investigator: Marc ESPIE, MD | |
| Sub-Investigator: Naïma BEDAIRIA, MD | |
| Sub-Investigator: Caroline CUVIER, MD | |
| Sub-Investigator: Sylvie GIACCHETTI, MD | |
| Sub-Investigator: Abdelhamid HOCINI, MD | |
| Hopital TENON | Recruiting |
| Paris, Ile de France, France, 75970 | |
| Contact: Daniel AVENIN, MD | |
| Principal Investigator: Daniel AVENIN, MD | |
| Sub-Investigator: Joseph GLIGOROV, MD | |
| Hopital gériatrique des Bateliers | Recruiting |
| Lille, Nord, France, 59037 | |
| Contact: François PUISIEUX, PD | |
| Principal Investigator: François PUISIEUX, PD | |
| CHRU Hôpital Claude Huriez | Recruiting |
| Lille, Nord, France, 59000 | |
| Contact: Mohamed HEBBAR, PD | |
| Principal Investigator: Mohamed HEBBAR, PD | |
| Sub-Investigator: Olivier ROMANO, MD | |
| Université | Recruiting |
| Lille, Nord, France, 59653 | |
| Contact: Véronique CHRISTOPHE, MD | |
| Principal Investigator: Véronique CHRISTOPHE, MD | |
| Centre Henri BECQUEREL | Recruiting |
| Rouen, Seine Maritime, France, 76038 | |
| Contact: Olivier RIGAL, MD | |
| Principal Investigator: Olivier RIGAL, MD | |
| Sub-Investigator: Corinne VEYRET, MD | |
| Sub-Investigator: Isabelle TENNEVET, MD | |
| Sub-Investigator: Marianne LEHEURTEUR, MD | |
| Sub-Investigator: Cécile GUILLEMET, MD | |
| Sub-Investigator: Annie CHEVRIER, MD | |
| Sub-Investigator: Emmanuel BLOT, MD | |
| CHU | Recruiting |
| Rouen, Seine Maritime, France, 76000 | |
| Contact: Pierre MICHEL, PD | |
| Principal Investigator: Pierre MICHEL, PD | |
| Sub-Investigator: Frédéric DI FIORE, MD | |
| Sub-Investigator: David TOUGERON, MD | |
| Sub-Investigator: Bernard PAILLOT, MD | |
| Sub-Investigator: Isabelle IWANICKI-CARON, MD | |
| CHU, Hôpital Bois Guillaume | Recruiting |
| Rouen, Seine Maritime, France, 76000 | |
| Contact: Philippe CHASSAGNE, MD | |
| Principal Investigator: Philippe CHASSAGNE, MD | |
| Hôpital Charles FOIX | Recruiting |
| IVRY sur SEINE, France, 94206 | |
| Contact: François PIETTE, PD | |
| Principal Investigator: François PIETTE, PD | |
| Sub-Investigator: Pascal CHAIBI, MD | |
| Sub-Investigator: Amale CHEBIB, MD | |
| Hopitaux universitaires | Recruiting |
| Strasbourg, France, 67091 | |
| Contact: Jean E KURTZ, PD | |
| Principal Investigator: Jean E Kurtz, PD | |
| Sub-Investigator: Fréderic BLANC, MD | |
| Sub-Investigator: Valère LITIQUE, MD | |
| Sub-Investigator: Sebastian SERRA, MD | |
| Sub-Investigator: Philippe BARTHELEMY, MD | |
| Sub-Investigator: Serge ROHR | |
| Sub-Investigator: Céline BRIGAND, MD | |
| Sub-Investigator: Carole MATHELIN, MD | |
| Sub-Investigator: Didier MUTTER, PD | |
Sponsors and Collaborators
Centre Francois Baclesse
National Cancer Institute, France
Sanofi
Investigators
| Principal Investigator: | Florence JOLY-LOBBEDEZ, PD | Centre François Baclesse |
More Information
No publications provided
| Responsible Party: | Pr Florence JOLY-LOBBEDEZ, Centre François Baclesse |
| ClinicalTrials.gov Identifier: | NCT01333735 History of Changes |
| Other Study ID Numbers: | COG AGE |
| Study First Received: | April 8, 2011 |
| Last Updated: | December 19, 2011 |
| Health Authority: | France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé |
Keywords provided by Centre Francois Baclesse:
|
cognitive functions quality of life breast cancer chemotherapy ages patients |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on May 22, 2013