Effects of chemotherapy on cognition and brain changes in older breast cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This research evaluates how chemotherapy affects cognitive function and brain structure in older adults diagnosed with breast cancer. The study aims to identify individuals at risk for cognitive impairment, often referred to as 'chemo-brain', by conducting memory and thinking tests alongside brain imaging techniques such as MRI and PET scans. Participants include both breast cancer patients undergoing chemotherapy and healthy volunteers, allowing for a comparative analysis of cognitive effects. The goal is to enhance understanding of chemotherapy's impact on brain health and cognition.

Why it matters

Who can join: the full rules

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 it's running

• Massachusetts General Hospital
  Boston, Massachusetts, United States Recruiting
• Massachusetts General Hospital/North Shore Cancer Center
  Salem, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Michael Parsons, PhD — Massachusetts General Hospital
• Study coordinator: Michael W Parsons, PhD
• Email: mwparsons@mgh.harvard.edu
• Phone: 617-643-0282

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.