Impaired CognitionNCT02290834
Chemotherapy-induced Cognitive and Brain Changes in Older Adults With Breast Cancer
A study testing Cognitive, functional and subjective assessments, MRI and PET Scan in people with Impaired Cognition and Chemo-brain, run by Massachusetts General Hospital at 2 sites in United States.
Trial summary
This research study evaluates the effect of chemotherapy on cognition (thinking) and the brain in people with breast cancer. Read more about this study
- Who is it for?
- Ages 60 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Impaired Cognition, Chemo-brain, Breast Cancer
- What is being tested?
- Cognitive, functional and subjective assessments, MRI and PET Scan
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2015to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Breast cancer patients treated with chemotherapy- Group 1 (experimental group)
- Participants must meet the following criteria on screening examination to be eligible to participate in the behavioral +/- imaging components of study
- New diagnosis histologically confirmed invasive breast cancer
- Treatment plan to include chemotherapy
- Female subjects age ≥ 60 years.
- Life expectancy ≥ 1 year
Show all 24Show fewer
- Karnofsky Performance Score (KPS) ≥ 80
- Ability to understand and the willingness to sign a written informed consent document.
- Non-treated breast cancer patient controls- Group 2 (control group)
- Participants must meet the following criteria on screening examination to be eligible to participate in the behavioral +/- imaging components of study:
- New diagnosis histologically confirmed invasive breast cancer
- Treatment plan does not include chemotherapy
- Age ≥ 60 years.
- Life expectancy ≥ 1 year
- Karnofsky Performance Score (KPS) ≥ 80
- Ability to understand and the willingness to sign a written informed consent document.
- Healthy control subjects- Group 3 (control group)
- Participants must meet the following criteria on screening examination to be eligible to participate in the behavioral +/- imaging components of study:
- Age ≥ 60 years.
- Life expectancy ≥ 1 year
- Karnofsky Performance Score (KPS) ≥ 80
- Ability to understand and the willingness to sign a written informed consent document.
- Participants with well-controlled vascular risk factors, such as treated hypertension, treated hyperlipidemia or well-controlled Type II diabetes (glucose levels <250) may be included.
- Serum Pregnancy Testing: STAT quantitative serum hCG pregnancy testing for all women of childbearing potential. Imaging will not start until and unless the test result returns negative.
Who cannot join
- Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study:
- Participants with clinical or radiographic evidence of metastatic CNS disease
- Subjects with MMSE scores below 24
- Active or history of major psychiatric disorders such as schizophrenia, schizoaffective disorder, major affective disorder in mid-life, or treatment with ECT (Mild depression that is well treated with stable dose of SSRI antidepressants may be allowed).
- Substance abuse within the past 2 years
- Huntington's disease, hydrocephalus or seizure disorder
- In addition to exclusion criteria above, participants who exhibit any of the following conditions at screening will not be eligible for admission into imaging portion of the study:
- Participants with contraindications to MRI (i.e., implanted metal including pacemakers, cerebral spinal fluid shunts, aneurysm clips, artificial heart valves, ear implants or metal/foreign objects in the eyes and those with a history of claustrophobia), injuries to the eyes with metal without X-ray documentation that metal was removed
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Michael Parsons, PhD, 617-643-0282, MWPARSONS@mgh.harvard.edu
Michael Parsons, PhD
- Recruiting
Massachusetts General Hospital/North Shore Cancer Center
Salem, Massachusetts, 01970
Therese Mulvey, MD, (678) 882-6060, TMMULVEY@PARTNERS.ORG
Therese Mulvey, MD
About this study
This research study evaluates the effect of chemotherapy on cognition (thinking) and the brain in people with breast cancer.
Read the detailed description
- This study is being done to study effects of chemotherapy (cancer treatment) on the brain and cognition (thinking). "Chemo-brain" is a term sometimes used to refer to effects of chemotherapy on the brain and cognition (thinking).
- This study is being done to test for "chemo-brain" in older adults with breast cancer treated with chemotherapy, and to identify people who are most likely to be affected. The investigators will look at thinking abilities and brain images before and after chemotherapy to see if it can help identify people at risk for cognitive side effects of the treatment, and to better understand effects of treatment on brain structure and function.
- The investigators are looking for participants who have either been recently recently diagnosed breast cancer participant or a healthy volunteer.
- What is involved in the study:
- Memory and Thinking Tests
- Imaging: Either MRI/or MRI and PET Scans
- Conditions
- Impaired Cognition, Chemo-brain, Breast Cancer
- Being tested
- Cognitive, functional and subjective assessments, MRI, PET Scan
- Keywords
- Chemotherapy related cognitive impairment, Chemo-brain
- Medical subject headings
- Cognition Disorders, Breast Neoplasms, Chemotherapy-Related Cognitive Impairment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive, functional and subjective assessmentsOther
Cognitive and functional assessments
MRIDevice
Magnetic Resonance Imaging (MRI) Scan
PET ScanRadiation
Positron Emission Tomography (PET) Scan
| Study group | Role | What they receive |
|---|---|---|
| ARM 1 | Active comparator | Breast cancer patients treated with chemotherapy
* Cognitive, functional and subjective assessments (Pre and Post Treatment)
* Imaging (Pre and Post Treatment)
* Magnetic Resonance Imaging (MRI) Scan
* Magnetic Resonance Imaging (MRI) Scan / Positron Emission Tomography (PET) Scan Receives: Other: Cognitive, functional and subjective assessments; Device: MRI; Radiation: PET Scan |
| ARM 2 | Active comparator | Non-treated breast cancer patient control
* Cognitive, functional and subjective assessments (Post enrollment and 6-14 months later
* Imaging (Post Enrollment and at 8-14 months later)
* Magnetic Resonance Imaging (MRI) Scan
* Magnetic Resonance Imaging (MRI) Scan / Positron Emission Tomography (PET) Scan Receives: Other: Cognitive, functional and subjective assessments; Device: MRI; Radiation: PET Scan |
| ARM 3 | Active comparator | Healthy control subjects
* Cognitive, functional and subjective assessments (Post enrollment and 6-14 months later
* Imaging (Post Enrollment and at 8-14 months later)
* Magnetic Resonance Imaging (MRI) Scan
* Magnetic Resonance Imaging (MRI) Scan / Positron Emission Tomography (PET) Scan Receives: Other: Cognitive, functional and subjective assessments; Device: MRI; Radiation: PET Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cognitive performance scores
Measured: Baseline, immediately after completion of chemo, and 6 months after completion of chemotherapy
Secondary outcomes (3)
Correlation between baseline amyloid accumulation in the brain and change in cognitive performance
Measured: Baseline, 6 months after completion of chemotherapy
Correlation between baseline tau accumulation in the brain and change in cognitive performance
Measured: Baseline, 6 months after completion of chemotherapy
Correlation between change in tau accumulation in the brain (from baseline to 6 months after completion of chemotherapy) and change in cognitive performance (from baseline to 6 months after completion of chemotherapy)
Measured: Baseline, 6 months after completion of chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2014 (estimated)
- Study startMar 2015
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impaired CognitionStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael W Parsons, Massachusetts General Hospital
- Investigators
- Michael Parsons, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02290834
- Sponsor's protocol ID
- 14-217
- Status last verified
- Jul 2026
- First submitted
- 5 Nov 2014
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: No data are yet available
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chemotherapy-induced Cognitive and Brain Changes in Older Adults With Breast Cancer
- ClinicalTrials.gov ID
- NCT02290834
- Acronym / sponsor ID
- 14-217
- Conditions
- Impaired Cognition, Chemo-brain, Breast Cancer
- Keywords
- Chemotherapy related cognitive impairment, Chemo-brain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 14 Nov 2014 (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.
This research study evaluates the effect of chemotherapy on cognition (thinking) and the brain in people with breast cancer.
Detailed description
- This study is being done to study effects of chemotherapy (cancer treatment) on the brain and cognition (thinking). "Chemo-brain" is a term sometimes used to refer to effects of chemotherapy on the brain and cognition (thinking).
- This study is being done to test for "chemo-brain" in older adults with breast cancer treated with chemotherapy, and to identify people who are most likely to be affected. The investigators will look at thinking abilities and brain images before and after chemotherapy to see if it can help identify people at risk for cognitive side effects of the treatment, and to better understand effects of treatment on brain structure and function.
- The investigators are looking for participants who have either been recently recently diagnosed breast cancer participant or a healthy volunteer.
- What is involved in the study:
- Memory and Thinking Tests
- Imaging: Either MRI/or MRI and PET Scans
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ARM 1 | Active comparator | Other: Cognitive, functional and subjective assessments, Device: MRI, Radiation: PET ScanBreast cancer patients treated with chemotherapy * Cognitive, functional and subjective assessments (Pre and Post Treatment) * Imaging (Pre and Post Treatment) * Magnetic Resonance Imaging (MRI) Scan * Magnetic Resonance Imaging (MRI) Scan / Positron Emission Tomography (PET) Scan |
| ARM 2 | Active comparator | Other: Cognitive, functional and subjective assessments, Device: MRI, Radiation: PET ScanNon-treated breast cancer patient control * Cognitive, functional and subjective assessments (Post enrollment and 6-14 months later * Imaging (Post Enrollment and at 8-14 months later) * Magnetic Resonance Imaging (MRI) Scan * Magnetic Resonance Imaging (MRI) Scan / Positron Emission Tomography (PET) Scan |
| ARM 3 | Active comparator | Other: Cognitive, functional and subjective assessments, Device: MRI, Radiation: PET ScanHealthy control subjects * Cognitive, functional and subjective assessments (Post enrollment and 6-14 months later * Imaging (Post Enrollment and at 8-14 months later) * Magnetic Resonance Imaging (MRI) Scan * Magnetic Resonance Imaging (MRI) Scan / Positron Emission Tomography (PET) Scan |
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Breast cancer patients treated with chemotherapy- Group 1 (experimental group)
- Non-treated breast cancer patient controls- Group 2 (control group)
- Healthy control subjects- Group 3 (control group)
Key exclusion criteria (8 listed)
- Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study:
- In addition to exclusion criteria above, participants who exhibit any of the following conditions at screening will not be eligible for admission into imaging portion of the study:
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, functional and subjective assessmentsCognitive and functional assessments | Other | ARM 1, ARM 2, ARM 3 |
| MRIMagnetic Resonance Imaging (MRI) Scan | Device | ARM 1, ARM 2, ARM 3 |
| PET ScanPositron Emission Tomography (PET) Scan | Radiation | ARM 1, ARM 2, ARM 3 |
Primary outcome
Change in cognitive performance scores
Time frame: Baseline, immediately after completion of chemo, and 6 months after completion of chemotherapy
3 secondary outcomes
Correlation between baseline amyloid accumulation in the brain and change in cognitive performance
Time frame: Baseline, 6 months after completion of chemotherapy
Correlation between baseline tau accumulation in the brain and change in cognitive performance
Time frame: Baseline, 6 months after completion of chemotherapy
Correlation between change in tau accumulation in the brain (from baseline to 6 months after completion of chemotherapy) and change in cognitive performance (from baseline to 6 months after completion of chemotherapy)
Time frame: Baseline, 6 months after completion of chemotherapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: Undecided. No data are yet available
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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.
Michael Parsons, PhD principal investigator
Massachusetts General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive, functional and subjective assessments, MRI and PET Scan in people with Impaired Cognition and Chemo-brain, run by Massachusetts General Hospital at 2 sites 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 24 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 16 Jul 2026. 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael W Parsons, PhD (617-643-0282, mwparsons@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cognitive performance scores (time frame: Baseline, immediately after completion of chemo, and 6 months after completion of 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 16 Jul 2026.