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Chemotherapy-induced Cognitive and Brain Changes in Older Adults With Breast Cancer

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
60 Years and older
Sex
Female only
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at how chemotherapy affects thinking and the brain in older adults with breast cancer. It includes people age 60 or older with newly diagnosed breast cancer, with or without planned chemotherapy, and healthy adults for comparison.

This research study evaluates the effect of chemotherapy on cognition (thinking) and the brain in people with breast cancer.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 60 or older.
  • For either breast cancer group: have newly diagnosed invasive breast cancer, confirmed by a tissue test. This means cancer has grown into nearby breast tissue.
  • For the chemotherapy group: be female and have a treatment plan that includes chemotherapy.
  • For the other breast cancer group: have a treatment plan that does not include chemotherapy.
  • Be expected to live at least 1 year.
  • Have a daily activity score (KPS) of at least 80, meaning you can do normal activities with some effort.
  • Be able to understand the study and agree to sign a consent form.
  • Healthy comparison group: well-controlled high blood pressure, high cholesterol, or type 2 diabetes may be allowed. Blood sugar must be below 250 for diabetes. Women who could become pregnant need a negative blood pregnancy test before brain scans.

Who can't join

  • Cancer that has spread to the brain or spinal cord, shown by an exam or scan.
  • A score below 24 on the MMSE, a test of memory and thinking.
  • Current or past major mental health disorders, such as schizophrenia or a major mood disorder in midlife, or past treatment with ECT (electrical brain treatment). Mild depression well controlled with a steady dose of an SSRI antidepressant may be allowed.
  • Substance abuse within the past 2 years.
  • Huntington’s disease, a brain disease that affects movement and thinking; hydrocephalus, fluid buildup in the brain; or a seizure disorder.
  • For brain scans only: implants or metal that make MRI unsafe, such as a pacemaker, fluid-drainage tube, aneurysm clip, artificial heart valve, ear implant, or metal or other objects in the eyes.
  • For brain scans only: a history of fear of small, closed spaces.
  • For brain scans only: a past eye injury involving metal without an X-ray showing the metal was removed.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (2)

MA