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


N/A
66 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

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

Inclusion 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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

impact of memory impairment

Outcome Description:

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

Outcome Time Frame:

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

Safety Issue:

No

Principal Investigator

Florence JOLY-LOBBEDEZ, PD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre François Baclesse

Authority:

France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé

Study ID:

COG AGE

NCT ID:

NCT01333735

Start Date:

December 2008

Completion Date:

January 2013

Related Keywords:

  • Breast Cancer
  • cognitive functions
  • quality of life
  • breast cancer
  • chemotherapy
  • ages patients
  • Breast Neoplasms

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