NCT02290834 · Massachusetts General Hospital
Chemotherapy-induced Cognitive and Brain Changes in Older Adults With Breast Cancer
What this study is about
This research study evaluates the effect of chemotherapy on cognition (thinking) and the brain in people with breast cancer.
View original scientific description
This research study evaluates the effect of chemotherapy on cognition (thinking) and the brain in people with breast cancer.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Boston, Massachusetts
- Salem, Massachusetts
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 11, 2026 · Source of record for eligibility and locations