Chemo-brain mystery: study dives into thinking changes in older breast cancer patients
NCT ID NCT02290834
First seen Jun 27, 2026 · Last updated Jul 17, 2026 · Updated 2 times
Summary
This study looks at how chemotherapy affects thinking and the brain in older adults (age 60+) with breast cancer. Researchers will track changes in memory and thinking skills, and use brain scans to see if certain proteins are linked to these changes. The goal is to better understand 'chemo-brain' and who might be most at risk.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Start date
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Mar 2015
- Expected to finish
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Jan 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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60 years and older
- Sex
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Female participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Criteria: * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Massachusetts General Hospital
RECRUITINGBoston, Massachusetts, 02114, United States
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Massachusetts General Hospital/North Shore Cancer Center
RECRUITINGSalem, Massachusetts, 01970, United States
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