Cognitive SymptomsCICINCT01578083
Chemotherapy-Induced Cognitive Impairment
An observational study of Cognitive Symptoms, run by Jay F. Piccirillo, MD at 1 site in United States.
Trial summary
The investigators overall research hypothesis is that systemic chemotherapy induces structural changes in the white matter of the brain as demonstrated with Diffusion Tensor Imaging (DTI) and functional changes in well-defined cortical neural networks as demonstrated by resting-state functional connectivity MRI… Read more about this study
- Who is it for?
- Ages 35 to 70 years, women only
- Conditions the study is for
- Cognitive Symptoms
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Dec 2012
- 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 35 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Breast cancer surviviors from Washington University's Siteman Cancer Center and from community at large.
Who may be able to join
- Participants must be females between 35 and 70 years of age.
- Participants must have been diagnosed with breast cancer and completed chemotherapy,within the preceding 2 years.
- Participants must have completed their intended full course of chemotherapy regimen at least 30 days prior to participation.
- Participants must have been diagnosed with invasive ductal or lobular BrCa Stages I, II, or III (American Joint Committee on Cancer (AJCC) staging manual, 7th edition, 2010).
- Participants must be able to read, write, and speak English fluently.
- Participants must be able to provide a valid informed consent.
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- Participants must have a life expectancy of greater than 6 months at the time they are approached for enrollment.
- Cases - Those who self-report CICI and are in the 75th percentile of scores on the Cognitive Failures Questionnaire (CFQ) and have a global rating of cognition response of "Extremely Affected" or "Strongly Affected"
- Controls - Those whose CFQ scores are in the lowest 25th percentile and who report that their daily life is not affected by cognitive impairment. Controls will be selected so that they are age (within 5 years)-matched to a Case.
Who cannot join
- • Participants with prior cancer diagnoses of other sites with evidence of active disease within the past year.
- Participants who have received skull-base radiation treatment within the past year for any reason. Skull-base radiation may contribute to the symptoms of CICI.
- Participants with active diagnoses of any acute or chronic brain-related neurological conditions that can alter normal brain anatomy or function, including Parkinson's disease, Multiple Sclerosis, Alzheimer's Disease, cerebral infarcts, , history of brain tumor(s), epilepsy, or dementia.
- Must not have a history of traumatic brain injury (loss of consciousness for > 15 min.)
- Participants with implanted metal objects not compatible with MRI, electrodes, pacemakers, intracardiac lines, or medication pumps.
- Participants who weigh over 350 pounds (weight limit on MRI machine).
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- Participants with a history of claustrophobia that will preclude undergoing MRI.
- Participants with an inability to lie flat for MRI.
- Any medical condition the PI determines would render the study unsafe or not in the best interest of the patient.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: The Neurobiology of Chemotherapy-Induced Cognitive Impairment
The investigators overall research hypothesis is that systemic chemotherapy induces structural changes in the white matter of the brain as demonstrated with Diffusion Tensor Imaging (DTI) and functional changes in well-defined cortical neural networks as demonstrated by resting-state functional connectivity MRI (rs-fcMRI). The investigators believe these structural and functional changes are responsible for the cognitive symptoms associated with chemotherapy-induced cognitive impairment (CICI).
The Specific Aim for this study is:
Read more
To assess the impact of chemotherapy on structural white matter as defined by DTI and functional cognitive networks as defined by rs-fcMRI by comparing a sample of breast cancer survivors with self-reported CICI to breast cancer survivors without CICI.
Hypothesis: Post-chemotherapy breast cancer patients with self-reported CICI will have abnormal structural connections characterized by DTI-defined disruptions in fractional anisotropy (FA) and mean diffusivity (MD) and abnormal functional connectivity characterized by rs-fcMRI-defined disruptions in cognitive networks when compared to patients without self-reported CICI.
Read the detailed description
Chemotherapy has been linked to cognitive impairments among breast cancer patients, especially in the domains of executive function (planning and problem solving), attention, learning, and information processing. The etiology of these chemotherapy-associated impairments remains unknown, although recent neuroimaging studies suggest that disruption of white matter integrity may play a role. With continued use of chemotherapy in breast cancer patients, this study's novel use of functional neuroimaging will be significant to better inform practitioners and patients of potential consequences to anticipate and serve as a starting point in the development of therapeutic interventions.
- Conditions
- Cognitive Symptoms
- Keywords
- Chemotherapy, Breast Cancer, Cognitive Impairment, Chemo brain
- Medical subject headings
- Neurobehavioral Manifestations, Breast Neoplasms, Cognitive Dysfunction
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 |
|---|---|---|
| Cognitive Impairment | With self-report cognitive impairment. | |
| No Cognitive Impairment | Without self-report cognitive impairment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in fractional anisotropy (FA) in one or more white matter tracts.
As compared with the controls, the breast cancer patients will show decreased fractional anisotropy (FA) in the frontal and temporal white matter (WM) tracts and.
Measured: post-chemotherapy. One time measure within one year of final dose of chemotherapy.
Secondary outcomes (2)
rs-fcMRI-defined disruptions in cognitive cortical networks
As compared with the controls, the breast cancer patients will show decreased functional integrity of the default mode network [DMN], associated with memory; the dorsal and ventral attention networks [DAN/VAN], involved in attention; and the Cognitive/Control network, involved in executive decision-making
Measured: post-chemotherapy: post-chemotherapy. One time measure within one year of final dose of chemotherapy.
Changes in Mean Diffusivity (MD) in one or more white matter tracks
As compared with the controls, the breast cancer patients will show increased mean diffusivity (MD) in frontal White Matter (WM).
Measured: Post Chemotherapy: post-chemotherapy. One time measure within one year of final dose of chemotherapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognitive SymptomsStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jay F. Piccirillo, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Washington University Siteman Cancer Center, Barnes-Jewish Hospital
- Responsible party
- Sponsor-investigator, Jay F. Piccirillo, MD, Washington University School of Medicine
- Investigators
- Jay F. Piccirillo, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01578083
- Sponsor's protocol ID
- 201203045
- Acronym
- CICI
- Status last verified
- Apr 2012
- First submitted
- 12 Apr 2012
- Last updated
- 26 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Piccirillo JF, Hardin FM, Nicklaus J, Kallogjeri D, Wilson M, Ma CX, Coalson RS, Shimony J, Schlaggar BL. Cognitive impairment after chemotherapy related to atypical network architecture for executive control. Oncology. 2015;88(6):360-8. doi: 10.1159/000370117. Epub 2015 Feb 7.
PubMed 25678046
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Neurobiology of Chemotherapy-Induced Cognitive Impairment
- ClinicalTrials.gov ID
- NCT01578083
- Acronym / sponsor ID
- CICI / 201203045
- Conditions
- Cognitive Symptoms
- Keywords
- Chemotherapy, Breast Cancer, Cognitive Impairment, Chemo brain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Jay F. Piccirillo, MDUniversity, hospital or other
- Collaborators
- Washington University Siteman Cancer Center, Barnes-Jewish Hospital
- Study start
- Apr 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 16 Apr 2012 (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 investigators overall research hypothesis is that systemic chemotherapy induces structural changes in the white matter of the brain as demonstrated with Diffusion Tensor Imaging (DTI) and functional changes in well-defined cortical neural networks as demonstrated by resting-state functional connectivity MRI (rs-fcMRI). The investigators believe these structural and functional changes are responsible for the cognitive symptoms associated with chemotherapy-induced cognitive impairment (CICI).
The Specific Aim for this study is:
To assess the impact of chemotherapy on structural white matter as defined by DTI and functional cognitive networks as defined by rs-fcMRI by comparing a sample of breast cancer survivors with self-reported CICI to breast cancer survivors without CICI.
Hypothesis: Post-chemotherapy breast cancer patients with self-reported CICI will have abnormal structural connections characterized by DTI-defined disruptions in fractional anisotropy (FA) and mean diffusivity (MD) and abnormal functional connectivity characterized by rs-fcMRI-defined disruptions in cognitive networks when compared to patients without self-reported CICI.
Detailed description
Chemotherapy has been linked to cognitive impairments among breast cancer patients, especially in the domains of executive function (planning and problem solving), attention, learning, and information processing. The etiology of these chemotherapy-associated impairments remains unknown, although recent neuroimaging studies suggest that disruption of white matter integrity may play a role. With continued use of chemotherapy in breast cancer patients, this study's novel use of functional neuroimaging will be significant to better inform practitioners and patients of potential consequences to anticipate and serve as a starting point in the development of therapeutic interventions.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Impairment | – | –With self-report cognitive impairment. |
| No Cognitive Impairment | – | –Without self-report cognitive impairment. |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Breast cancer surviviors from Washington University's Siteman Cancer Center and from community at large.
Key inclusion criteria (9 listed)
- Participants must be able to read, write, and speak English fluently.
- Participants must be able to provide a valid informed consent.
- Participants must have a life expectancy of greater than 6 months at the time they are approached for enrollment.
- Cases - Those who self-report CICI and are in the 75th percentile of scores on the Cognitive Failures Questionnaire (CFQ) and have a global rating of cognition response of "Extremely Affected" or "Strongly Affected"
- Controls - Those whose CFQ scores are in the lowest 25th percentile and who report that their daily life is not affected by cognitive impairment. Controls will be selected so that they are age (within 5 years)-matched to a Case.
Key exclusion criteria (9 listed)
- • Participants with prior cancer diagnoses of other sites with evidence of active disease within the past year.
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
Changes in fractional anisotropy (FA) in one or more white matter tracts.
Time frame: post-chemotherapy. One time measure within one year of final dose of chemotherapy.
As compared with the controls, the breast cancer patients will show decreased fractional anisotropy (FA) in the frontal and temporal white matter (WM) tracts and.
2 secondary outcomes
rs-fcMRI-defined disruptions in cognitive cortical networks
Time frame: post-chemotherapy: post-chemotherapy. One time measure within one year of final dose of chemotherapy.
Changes in Mean Diffusivity (MD) in one or more white matter tracks
Time frame: Post Chemotherapy: post-chemotherapy. One time measure within one year of final dose of 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 26 Feb 2013.
- Derived from this study: PubMed 25678046Piccirillo JF, Hardin FM, Nicklaus J, Kallogjeri D, Wilson M, Ma CX, Coalson RS, Shimony J, Schlaggar BL. Cognitive impairment after chemotherapy related to atypical network architecture for executive control. Oncology. 2015;88(6):360-8. doi: 10.1159/000370117. Epub 2015 Feb 7.
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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.
Jay F. Piccirillo, MD principal investigator
Washington University School of Medicine
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 Cognitive Symptoms, run by Jay F. Piccirillo, MD 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 9 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 26 Feb 2013. 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?
Changes in fractional anisotropy (FA) in one or more white matter tracts. (time frame: post-chemotherapy. One time measure within one year of final dose of chemotherapy.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01578083, which also lists 1 linked publication.
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 26 Feb 2013.