Breast CancerCOG AGENCT01333735
Impact on Cognitive Function and Quality of Life of Adjuvant Chemotherapy in Patients Aged Over 65 Years: Application to Breast Cancer or Colon
An observational study of Breast Cancer, run by Centre Francois Baclesse at 15 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 66 years and older, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 114 participants
- Where
- 15 sitesin 2 countries
- Study dates
- Dec 2008to Jul 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 66 years and older
- Women only
- No healthy volunteers
- Older adult
Study population: patients with chemotherapy group and patients without chemotherapy group (control group)
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- Pathology psychiatric evolutionary
- Refusal of participation
- Patients unable to meet the cognitive tests
- Drug use
- Heavy drinking
Trial locations and contacts
15 sites in 2 countries.
15 sites in 2 countries
France14 sites
INSERM
Caen, Calvados, 14000
CHU
Caen, Calvados, 14033
Centre François BACLESSE
Caen, Calvados, 14076
Hôpital Charles FOIX
Ivry-sur-Seine, 94206
CHRU Hôpital Claude Huriez
Lille, Nord, 59000
Hopital gériatrique des Bateliers
Lille, Nord, 59037
Université
Lille, Nord, 59653
Hôpital Saint-Louis
Paris, Île-de-France Region, 75475
Hopital Pitié-Sapètrière
Paris, Île-de-France Region, 75651
Hopital TENON
Paris, Île-de-France Region, 75970
CHU, Hôpital Bois Guillaume
Rouen, Seine Maritime, 76000
CHU
Rouen, Seine Maritime, 76000
Centre Henri BECQUEREL
Rouen, Seine Maritime, 76038
Hopitaux universitaires
Strasbourg, 67091
About this study
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
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Studying the correlations between disorders of cognitive functions and parameters of quality of life
Measured: Before chemotherapy (baseline), end of chemotherapy and follow-up up to 24 months after chemotherapy
Relationship between performance and onco-geriatric cognitive
Examine the relationship between performance and onco-geriatric cognitive
Measured: Before chemotherapy (baseline), end of chemotherapy and follow-up up to 24 months after chemotherapy
Biological disturbances
Search for biological disturbances may be related to cognitive impairment observed
Measured: Before chemotherapy (baseline), end of chemotherapy and follow-up up to 24 months after chemotherapy
Impact of age
Assess the impact of age on the magnitude of cognitive impairment in patients
Measured: Before chemotherapy (baseline), end of chemotherapy and follow-up up to 24 months after chemotherapy
lived of the entourage
- Assess the impact and cognitive impairment of patients'experiences of the circle (translational research)
Measured: Before chemotherapy (baseline), end of chemotherapy and follow-up up to 12 months after chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2011 (estimated)
- Study startDec 2008
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Francois Baclesse
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute, France, Sanofi
- Investigators
- Florence JOLY-LOBBEDEZ, PD, Principal investigator, Centre François Baclesse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01333735
- Sponsor's protocol ID
- COG AGE
- Acronym
- COG AGE
- Status last verified
- Sep 2015
- First submitted
- 8 Apr 2011
- Last updated
- 4 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01333735
- Acronym / sponsor ID
- COG AGE / COG AGE
- Conditions
- Breast Cancer
- Keywords
- cognitive functions, quality of life, breast cancer, chemotherapy, ages patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Centre Francois BaclesseUniversity, hospital or other
- Collaborators
- National Cancer Institute, France, Sanofi
- Study start
- Dec 2008
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 12 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 66 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- patients with chemotherapy group and patients without chemotherapy group (control group)
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
5 secondary outcomes
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
Relationship between performance and onco-geriatric cognitive
Time frame: Before chemotherapy (baseline), end of chemotherapy and follow-up up to 24 months after chemotherapy
Biological disturbances
Time frame: Before chemotherapy (baseline), end of chemotherapy and follow-up up to 24 months after chemotherapy
Impact of age
Time frame: Before chemotherapy (baseline), end of chemotherapy and follow-up up to 24 months after chemotherapy
lived of the entourage
Time frame: Before chemotherapy (baseline), end of chemotherapy and follow-up up to 12 months after chemotherapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Florence JOLY-LOBBEDEZ, PD principal investigator
Centre François Baclesse
15 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Centre Francois Baclesse at 15 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in France, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
impact of memory impairment (time frame: Before chemotherapy (baseline), end of chemotherapy and follow-up up to 24 months after chemotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2015.