Breast CancerPhase 2CANMEMNCT01332916
Impact of Cancer on Memory Functioning: Understanding Disorders Using Approaches in Neuropsychology and Neuroimaging
A Phase 2 study testing cognitive tests and cerebral IRM in people with Breast Cancer and Healthy, run by Centre Francois Baclesse at 2 sites in France.
Trial summary
The purpose of this study is to investigate memory problems in patients with cancer. Read more about this study
- Who is it for?
- Ages 45 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Healthy
- What is being tested?
- cognitive tests and cerebral IRM
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesFrance
- Study dates
- Dec 2010to Apr 2014
- Phase
- Phase 2
- 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 45 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients aged 45 and over
- Patients from Grade 3 'end of primary schooling "minimum (scale Barbizet)
- Non-Metastatic Breast Cancer
- Adjuvant Chemotherapy: FEC, including Docetaxel Protocols
- No major cognitive impairment
- No previous neurological
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- Lack of personality disorders and psychiatric disorders evolutionary
- Having signed the informed consent of study participation
- Women from the general population aged 45 and over, and matched in age and cultural level in patients
- Topics of Grade 3 'end of primary schooling "minimum (scale Barbizet)
- No prior cancer
- No major cognitive impairment
- No previous neurological
- Lack of personality disorders and psychiatric disorders evolutionary
- Participating in the IMAP Protocol No. ID-BCR: 2007-A00414-49 or IMAP+(n° ID RCB 2011-A01493-38)(see how the study below) have signed forms no objection and consent to study participation
Who cannot join
- Traduction (français > anglais)
- Metastatic
- Cancer of the breast other than primitive
- Patients with paraneoplastic syndrome
- Patients under 45 years
- Patients whose achievement is below level 3 'end of primary schooling "(scale Barbizet)
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- Patients with adjuvant chemotherapy is associated with targeted therapy
- Patients who have received other cancer treatments (chemotherapy or radiotherapy brain)
- Contraindication to the implementation of an MRI (claustrophobia, metal objects in the body)
- disorders of higher functions existing in the administration of chemotherapy
- Neurologic earlier
- Pathology psychiatric evolutionary
- Refusal of participation
- Patients unable to meet the cognitive tests
- Drug use
- Heavy drinking
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre de recherche CYCERON
Caen, Calvados, 14076
Centre François BACLESSE
Caen, Calvados, 14076
About this study
The purpose of this study is to investigate memory problems in patients with cancer.
- Conditions
- Breast Cancer, Healthy
- Being tested
- cognitive tests and cerebral IRM
- Keywords
- No metastatic breast cancer, cognitive troubles, adjuvant chemotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive tests and cerebral IRMProcedure or surgery
cognitive tests and cerebral IRM
cognitive tests and cerebral IRMProcedure or surgery
cognitive tests and cerebral IRM
| Study group | Role | What they receive |
|---|---|---|
| patients aged 45 and over group | Experimental | patients aged 45 and over with breast cancer and should receive an adjuvant chemotherapy Receives: Procedure: cognitive tests and cerebral IRM |
| healthy volunteers (controls) aged 45 and over | Active comparator | healthy volunteers (controls) aged 45 and over Receives: Procedure: cognitive tests and cerebral IRM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the relationship between memory impairment and brain dysfunction
The main objective is to assess the relationship between memory impairment and brain dysfunction in patients treated with adjuvant chemotherapy for breast cancer (before and after treatment), compared to a group of healthy subjects.
Measured: Before chemotherapy (baseline), end of chemotherapy and follow-up up to 12 months after chemotherapy
Secondary outcomes (1)
Impact of age
The secondary objective is to assess the impact of age on the extent of memory impairment.
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 posted11 Apr 2011 (estimated)
- Study startDec 2010
- Primary completionDec 2013
- Study completionApr 2014
Why it stopped: lack of patient
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
- Interventional
- Phase
- Phase 2
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Francois Baclesse
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01332916
- Sponsor's protocol ID
- CANMEM
- Acronym
- CANMEM
- Status last verified
- May 2012
- First submitted
- 8 Apr 2011
- Last updated
- 25 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Cancer on Memory Functioning: Understanding Disorders Using Approaches in Neuropsychology and Neuroimaging
- ClinicalTrials.gov ID
- NCT01332916
- Acronym / sponsor ID
- CANMEM / CANMEM
- Conditions
- Breast Cancer, Healthy
- Keywords
- No metastatic breast cancer, cognitive troubles, adjuvant chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of patient
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Centre Francois BaclesseUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 11 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 purpose of this study is to investigate memory problems in patients with cancer.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients aged 45 and over group | Experimental | Procedure: cognitive tests and cerebral IRMpatients aged 45 and over with breast cancer and should receive an adjuvant chemotherapy |
| healthy volunteers (controls) aged 45 and over | Active comparator | Procedure: cognitive tests and cerebral IRMhealthy volunteers (controls) aged 45 and over |
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patients aged 45 and over
- Patients from Grade 3 'end of primary schooling "minimum (scale Barbizet)
- Non-Metastatic Breast Cancer
- Adjuvant Chemotherapy: FEC, including Docetaxel Protocols
- No major cognitive impairment
Key exclusion criteria (16 listed)
- Traduction (français > anglais)
- Metastatic
- Cancer of the breast other than primitive
- Patients with paraneoplastic syndrome
- Patients under 45 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cognitive tests and cerebral IRMcognitive tests and cerebral IRM | Procedure or surgery | patients aged 45 and over group |
| cognitive tests and cerebral IRMcognitive tests and cerebral IRM | Procedure or surgery | healthy volunteers (controls) aged 45 and over |
Primary outcome
Assess the relationship between memory impairment and brain dysfunction
Time frame: Before chemotherapy (baseline), end of chemotherapy and follow-up up to 12 months after chemotherapy
The main objective is to assess the relationship between memory impairment and brain dysfunction in patients treated with adjuvant chemotherapy for breast cancer (before and after treatment), compared to a group of healthy subjects.
1 secondary outcome
Impact of age
Time frame: Before chemotherapy (baseline), end of chemotherapy and follow-up up to 12 months after chemotherapy
Results and safety
The study was stopped early (reason given: lack of patient). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing cognitive tests and cerebral IRM in people with Breast Cancer and Healthy, run by Centre Francois Baclesse at 2 sites in France.
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 15 inclusion and 16 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: stopped early, as of the sponsor's last update on 25 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: lack of patient). Results are not available in the source record.
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?
Assess the relationship between memory impairment and brain dysfunction (time frame: Before chemotherapy (baseline), end of chemotherapy and follow-up up to 12 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 25 Apr 2014.