Chemotherapy's Effect on Thinking and Brain in Older Adults with Breast Cancer
This study is looking at how chemotherapy for breast cancer affects thinking abilities (cognition) and the brain in women aged 60 and older. Researchers want to understand "chemo-brain," a term for changes in thinking after chemotherapy. You would have memory and thinking tests, and possibly MRI and PET scans, before and after chemotherapy. The goal is to see if these tests can help identify who might experience these cognitive side effects and to better understand how treatment impacts the brain. This study is for women newly diagnosed with invasive breast cancer who will be treated with chemotherapy, or healthy volunteers.
- Study design
- This interventional study plans to enroll 200 participants. It is looking at breast cancer patients treated with chemotherapy (experimental group) and healthy volunteers.
- What's involved
- You would undergo memory and thinking tests, and imaging (MRI and/or PET scans). These assessments would happen at the start, immediately after chemotherapy, and 6 months after chemotherapy finishes.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your cognitive performance will be checked immediately after chemotherapy and again 6 months after chemotherapy is completed.
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NCT02290834
Chemotherapy-induced Cognitive and Brain Changes in Older Adults With Breast Cancer
Recruiting
NAAges 60+InterventionalDiagnosticMassachusetts General HospitalInvestigator-initiated
~200 participants
Updated 2026-07-16 on ClinicalTrials.gov
What's tested:Cognitive, functional and subjective assessmentsMRIPET Scan
At a glance
Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in cognitive performance scores
Measured over Baseline, immediately after completion of chemo, and 6 months after completion of chemotherapy
Conditions
Where it's being run
2 sites across 1 statesMassachusetts2
Study leadership
- Michael Parsons, PhD · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
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.
Exclusion
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
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
What this trial measures
- Change in cognitive performance scoresBaseline, immediately after completion of chemo, and 6 months after completion of chemotherapy