Breast CancerNCT00550134
Cognitive Changes Associated With Breast Cancer Treatment
An observational study of Breast Cancer and Cognitive Side Effects of Cancer Treatments, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
Patients with cancer often complain that their "mind does not seem to be clear." This can be due to stress, depression, anxiety, or physical problems caused by cancer or the treatments used to control symptoms. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Cognitive Side Effects of Cancer Treatments, Stage I, II and III A Breast Cancer
- What is being tested?
- Questionnaires, MRI, Comet assay and Cell senescence
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Oct 2007to 28 Dec 2021
- 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 18 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Potential subjects for the study will be identified MSKCC's clinic. Healthy control group participants will be recruited through advertisements and flyers which will be available/advertised in the community. Health control participants will also be recruited by asking survivors if they have a friend who might want to volunteer for the study.
Who may be able to join
- Patient is 18 years of age but not older than 70years of age
- Patient is female
- Patient is able to understand English, through verbal and written communication
- In the judgment of the investigator and/or the consenting professional patient is able to provide informed consent
- Patient has a diagnosis of breast cancer (stage 0, I, II or IIIA-C), limited to localized disease,
- Patient is chemotherapy naïve and is receiving chemotherapy or is scheduled to receive no chemotherapy as part of adjuvant treatment
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- Patient does not report history of prior breast or other cancer with the exception of non-melanoma skin cancer and/or participants who completed treatment for a previous cancer at least 5 years ago and have not undergone any chemotherapy.
- Patient is able to undergo MRI scanning (verified with pre MRI Safety Screening form),
- Patient can comfortably fit inside the MRI machine, verified by back to chest measurement no more than 10 inches or bust circumference of no more than 48 inches.
Who cannot join
- Patient has documented evidence of cognitive compromise (Blessed- Orientation Memory Cognition Test score > 11
- Patient has a history of neurological disorder with cognitive symptoms (e.g., Alzheimer's disease, Parkinson's disease, multiple sclerosis)
- Patient is Pregnant as confirmed by urine pregnancy test. Participants who are post menopausal or have had a hysterectomy do not need a pregnancy test
- Patient is currently on daily medication for migraine or, insulin-dependent diabetes requiring administration by injection,
- Patient has uncontrollable hypertension as per self report or as documented in the medical record
- Patient has a reported fear of enclosed spaces (Claustrophobia)
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- Patient has any of the following items that preclude fMRI evaluation
- Cardiac pacemaker, Joint replacements, Aneurysm clips, Transdermal patched, Aortic clips, Prosthesis, Intracranial bypass clips, Harrington rod , Coronary Artery bypass clips, Biostimulator, Renal Transplant Clips, Bone or joint pins, Other vascular clips or filters, Tissue expander ,Implanted neurostimulators, Metal mesh, Artificial heart valve, Stents, Insulin pump, Wire structures, Electrodes, Shrapnel/bullets, Hearing Aids implant, Implanted electrical devices, IUD, Metal in eyes, Shunts, Ocular Implants, Hair extensions, Hair implants, Tattoos above the waist, Any possible metal in body
- Patient has dentures, body jewelry or wig that they are unable to remove
- History of head injury with evidence of brain injury or loss of consciousness for > 60 minutes or cognitive sequelae
- Untreated or current episode of depression (answering positively to either of the two screening questions from the PHQ-9 (Kroenke, et al., 2001)
- Self-reported sleep disorders that could influence cognitive functioning including sleep apnea and and narcolepsy
- History of Axis I psychiatric disorder (DSM-IV), major affective disorder (untreated), bipolar disorder, schizophrenia disorder (DSM-IV) or substance use disorders (self reported and/or stated in medical record)
- History of schizophrenia, bipolar disorder or substance use disorders
- Patient is unwilling to undergo fMRI component if selected
- Patient has undergone previous chemotherapy treatment
- Healthy Control Inclusion Criteria:
- Participant is 18 years of age but not older than 70 years of age,
- Participant is female
- Participant is able to understand English, through verbal and written communication
- In the judgment of the investigator and/or the consenting professional participant is able to provide informed consent
- Patient is able to undergo MRI scanning (verified with pre MRI Safety Screening form)
- Patient can comfortably fit inside the MRI machine, verified by back to chest measurement no more than 10 inches or bust circumference of no more than 48 inches.
- Healthy Control Exclusion Criteria:
- -Participant has Documented evidence of severe cognitive compromise (Blessed- Orientation Memory Cognition Test score > 11
- Participant has a history of neurological disorder with cognitive symptoms (e.g., Alzheimer's disease, Parkinson's disease, multiple sclerosis).
- Participant is pregnant as indicated by urine pregnancy test,
- As per self report participant is currently on daily medication for migraine, or , insulin dependent diabetes requiring administration by injection,
- As per self report participant has uncontrollable hypertension,
- As per self report, participant has a reported fear of enclosed spaces (Claustrophobia)
- As per self report, participant has any of the following items that preclude fMRI evaluation Cardiac pacemaker, Joint replacements, Aneurysm clips, Transdermal patched, Aortic clips Prosthesis, Intracranial bypass clips, Harrington rod , Coronary Artery bypass clips, Biostimulator, Renal Transplant Clips, Bone or joint pins, Other vascular clips or filters, Tissue expander ,Implanted neurostimulators, Metal mesh, Artificial heart valve, Stents, Insulin pump, Wire structures, Electrodes, Shrapnel/bullets, Hearing Aids implant, Implanted electrical devices, IUD, Metal in eyes, Shunts, Ocular Implants, Hair extensions, Hair implants, Tattoos above the waist, Any possible metal in body
- As per self report, participant has dentures, body jewelry or wig that they are unable to remove
- As per self report, participant has a history of head injury with evidence of brain injury or loss of consciousness for > 60 minutes or cognitive sequelae
- As per self report, participant has untreated or current episode of depression (answering positively to either of the two screening questions from the PHQ-9 (Kroenke, et al., 2001)
- As per self report, participant has sleep disorders that could influence cognitive functioning including sleep apnea and narcolepsy,
- As per self report, participant has history of Axis I psychiatric disorder (DSM-IV), major affective disorder (untreated), bipolar disorder, schizophrenia disorder (DSM-IV) or substance use disorders
- As per self report, participant has undergone previous chemotherapy treatment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Patients with cancer often complain that their "mind does not seem to be clear." This can be due to stress, depression, anxiety, or physical problems caused by cancer or the treatments used to control symptoms. There are many purposes for this study; one of them is to learn about the effects of cancer treatments on the brain, and another is to identify useful tools to detect these effects. The results of this study may stimulate new research comparing different treatments to the current treatment so the researchers may learn how to treat symptoms more effectively and improve patient quality of life. We would also like to learn more about the effects chemotherapy may have on DNA.
Read the detailed description
This is a prospective, longitudinal study to examine time-dependent neurocognitive changes in patients with breast cancer receiving adjuvant chemotherapy. This study will assess chemotherapy-induced cognitive dysfunction. The researchers will recruit patients with localized breast cancer undergoing adjuvant chemotherapy for the first time and will test the effects of chemotherapy on patients' cognitive function utilizing a standardized neuropsychological battery. Patients scheduled for chemotherapy will be given a battery of neuropsychological undergo MRI evaluation prior to beginning chemotherapy and one month following completion of treatment.
- Conditions
- Breast Cancer, Cognitive Side Effects of Cancer Treatments, Stage I, II and III A Breast Cancer
- Being tested
- Questionnaires, MRI, Comet assay and Cell senescence
- Keywords
- Breast Cancer, Quality of life
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaires, MRI, Comet assay and Cell senescenceBehavioural
Also called Wide Range Achievement Test - Reading subtest (WRAT 4, 43), Phonemic Verbal Fluency (44), California Verbal Learning Test II (45), Logical Memory I and II (WMS III, 46)
Neuropsychological and psychological testing MRI, Comet assay and Cell senescence
Questionnaires, MRI, Comet assay and Cell senescenceBehavioural
Also called Wide Range Achievement Test -Reading subtest (WRAT 4, 43), Phonemic Verbal Fluency (44), California Verbal Learning Test II (45), Logical Memory I and II (WMS III, 46)
Neuropsychological and psychological testing MRI, Comet assay and Cell senescence
Questionnaires, MRI, Comet assay and Cell senescenceBehavioural
Also called Wide Range Achievement Test -Reading subtest (WRAT 4, 43), Phonemic Verbal Fluency (44), California Verbal Learning Test II (45), Logical Memory I and II (WMS III, 46)
Neuropsychological and psychological testing, MRI, Comet assay and Cell senescence
| Study group | Role | What they receive |
|---|---|---|
| 1, Non Cancer group | A noncancer control group (N=35), frequency matched on age (< 50 and ≥ 50) and education (less than college or some college and above) will also be recruited and evaluated with the same neuropsychological test battery on a schedule that matches the inter-test interval of the patients. Receives: Behavioral: Questionnaires, MRI, Comet assay and Cell senescence | |
| 2 Breast Cancer Patients Scheduled for chemotherapy | We will recruit patients with localized breast cancer undergoing adjuvant chemotherapy for the first time and will test the effects of chemotherapy will be given a battery of neuropsychological tests and an MRI evaluation prior to beginning chemotherapy and approximately one month (plus/minus 4 weeks) following completion of treatment. Receives: Behavioral: Questionnaires, MRI, Comet assay and Cell senescence | |
| 3 Breast Cancer Patients Not Scheduled for Chemotherapy | We will recruit patients with localized breast cancer not undergoing adjuvant chemotherapy. Receives: Behavioral: Questionnaires, MRI, Comet assay and Cell senescence |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate changes in cognitive performance pre- to post-chemotherapy in breast cancer patients.
Measured: approximately 4 to 6 months from baseline, depending on chemotherapy regimen
Secondary outcomes (2)
To evaluate associations between changes in frontal cortex and hippocampal volumes and activation patterns and changes in neuropsychological test performance.
Measured: 4 to 6 months
To evaluate the relationship between change in level of oxidative DNA damage markers of cell senescence (Telomere attrition) and changes in volume and activation patterns in prefrontal cortex and hippocampus.
Measured: 4 to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2007 (estimated)
- Study start24 Oct 2007
- Primary completion28 Dec 2021
- Study completion28 Dec 2021
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.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Weill Medical College of Cornell University, The City College of New York, Brigham and Women's Hospital, Biomedical Engineering Newark College of Engineering New Jersey Institute of Technology
- Responsible party
- Sponsor
- Investigators
- Tim Ahles, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00550134
- Sponsor's protocol ID
- 07-130
- Status last verified
- Dec 2021
- First submitted
- 25 Oct 2007
- Last updated
- 30 Dec 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Changes Associated With Breast Cancer Treatment
- ClinicalTrials.gov ID
- NCT00550134
- Acronym / sponsor ID
- 07-130
- Conditions
- Breast Cancer, Cognitive Side Effects of Cancer Treatments, Stage I, II and III A Breast Cancer
- Keywords
- Breast Cancer, Quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Weill Medical College of Cornell University, The City College of New York, Brigham and Women's Hospital, Biomedical Engineering Newark College of Engineering New Jersey Institute of Technology
- Study start
- 24 Oct 2007 (actual)
- Primary completion
- 28 Dec 2021 (actual)
- Study completion
- 28 Dec 2021 (actual)
- First posted
- 29 Oct 2007 (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.
Patients with cancer often complain that their "mind does not seem to be clear." This can be due to stress, depression, anxiety, or physical problems caused by cancer or the treatments used to control symptoms. There are many purposes for this study; one of them is to learn about the effects of cancer treatments on the brain, and another is to identify useful tools to detect these effects. The results of this study may stimulate new research comparing different treatments to the current treatment so the researchers may learn how to treat symptoms more effectively and improve patient quality of life. We would also like to learn more about the effects chemotherapy may have on DNA.
Detailed description
This is a prospective, longitudinal study to examine time-dependent neurocognitive changes in patients with breast cancer receiving adjuvant chemotherapy. This study will assess chemotherapy-induced cognitive dysfunction. The researchers will recruit patients with localized breast cancer undergoing adjuvant chemotherapy for the first time and will test the effects of chemotherapy on patients' cognitive function utilizing a standardized neuropsychological battery. Patients scheduled for chemotherapy will be given a battery of neuropsychological undergo MRI evaluation prior to beginning chemotherapy and one month following completion of treatment.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1, Non Cancer group | – | Behavioral: Questionnaires, MRI, Comet assay and Cell senescenceA noncancer control group (N=35), frequency matched on age (< 50 and ≥ 50) and education (less than college or some college and above) will also be recruited and evaluated with the same neuropsychological test battery on a schedule that matches the inter-test interval of the patients. |
| 2 Breast Cancer Patients Scheduled for chemotherapy | – | Behavioral: Questionnaires, MRI, Comet assay and Cell senescenceWe will recruit patients with localized breast cancer undergoing adjuvant chemotherapy for the first time and will test the effects of chemotherapy will be given a battery of neuropsychological tests and an MRI evaluation prior to beginning chemotherapy and approximately one month (plus/minus 4 weeks) following completion of treatment. |
| 3 Breast Cancer Patients Not Scheduled for Chemotherapy | – | Behavioral: Questionnaires, MRI, Comet assay and Cell senescenceWe will recruit patients with localized breast cancer not undergoing adjuvant chemotherapy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Potential subjects for the study will be identified MSKCC's clinic. Healthy control group participants will be recruited through advertisements and flyers which will be available/advertised in the community. Health control participants will also be recruited by asking survivors if they have a friend who might want to volunteer for the study.
Key inclusion criteria (9 listed)
- Patient is 18 years of age but not older than 70years of age
- Patient is female
- Patient is able to understand English, through verbal and written communication
- In the judgment of the investigator and/or the consenting professional patient is able to provide informed consent
- Patient has a diagnosis of breast cancer (stage 0, I, II or IIIA-C), limited to localized disease,
Key exclusion criteria (37 listed)
- Patient has documented evidence of cognitive compromise (Blessed- Orientation Memory Cognition Test score > 11
- Patient has a history of neurological disorder with cognitive symptoms (e.g., Alzheimer's disease, Parkinson's disease, multiple sclerosis)
- Patient is Pregnant as confirmed by urine pregnancy test. Participants who are post menopausal or have had a hysterectomy do not need a pregnancy test
- Patient is currently on daily medication for migraine or, insulin-dependent diabetes requiring administration by injection,
- Patient has uncontrollable hypertension as per self report or as documented in the medical record
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 |
|---|---|---|
| Questionnaires, MRI, Comet assay and Cell senescenceAlso: Wide Range Achievement Test - Reading subtest (WRAT 4, 43), Phonemic Verbal Fluency (44), California Verbal Learning Test II (45), Logical Memory I and II (WMS III, 46)Neuropsychological and psychological testing MRI, Comet assay and Cell senescence | Behavioural | 1, Non Cancer group |
| Questionnaires, MRI, Comet assay and Cell senescenceAlso: Wide Range Achievement Test -Reading subtest (WRAT 4, 43), Phonemic Verbal Fluency (44), California Verbal Learning Test II (45), Logical Memory I and II (WMS III, 46)Neuropsychological and psychological testing MRI, Comet assay and Cell senescence | Behavioural | 2 Breast Cancer Patients Scheduled for chemotherapy |
| Questionnaires, MRI, Comet assay and Cell senescenceAlso: Wide Range Achievement Test -Reading subtest (WRAT 4, 43), Phonemic Verbal Fluency (44), California Verbal Learning Test II (45), Logical Memory I and II (WMS III, 46)Neuropsychological and psychological testing, MRI, Comet assay and Cell senescence | Behavioural | 3 Breast Cancer Patients Not Scheduled for Chemotherapy |
Primary outcome
To evaluate changes in cognitive performance pre- to post-chemotherapy in breast cancer patients.
Time frame: approximately 4 to 6 months from baseline, depending on chemotherapy regimen
2 secondary outcomes
To evaluate associations between changes in frontal cortex and hippocampal volumes and activation patterns and changes in neuropsychological test performance.
Time frame: 4 to 6 months
To evaluate the relationship between change in level of oxidative DNA damage markers of cell senescence (Telomere attrition) and changes in volume and activation patterns in prefrontal cortex and hippocampus.
Time frame: 4 to 6 months
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 30 Dec 2021.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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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.
Tim Ahles, PhD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Cognitive Side Effects of Cancer Treatments, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
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 9 inclusion and 37 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 30 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
To evaluate changes in cognitive performance pre- to post-chemotherapy in breast cancer patients. (time frame: approximately 4 to 6 months from baseline, depending on chemotherapy regimen). 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 30 Dec 2021.