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NCT Number: NCT01333735

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

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.

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Key information

Conditions

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

Age range

66 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Université, Brussels, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. impact of memory impairment

    Time frame: 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 outcomes

  1. 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

    Studying the correlations between disorders of cognitive functions and parameters of quality of life

  2. Relationship between performance and onco-geriatric cognitive

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

    Examine the relationship between performance and onco-geriatric cognitive

  3. Biological disturbances

    Time frame: 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

  4. Impact of age

    Time frame: 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

  5. lived of the entourage

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Centre Francois Baclesse

Other

Collaborators

  • National Cancer Institute, France
  • Sanofi

Registry information

Acronym: COG AGE

Important dates

Study start
2008
Primary completion
2015
Study completion
2015
First posted
Apr 12, 2011
Registry last updated
Sep 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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