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

Launched by MASSACHUSETTS GENERAL HOSPITAL · Nov 11, 2014

Keywords

ClinConnect Summary

This clinical trial is studying how chemotherapy affects thinking and brain function in older women with breast cancer. Researchers want to understand if the treatment leads to changes in cognition, commonly referred to as "chemo-brain," which can cause memory problems and difficulties with focus. The study will include three groups: women aged 60 and older who are currently receiving chemotherapy for their newly diagnosed breast cancer, women of the same age who have breast cancer but are not getting chemotherapy, and healthy women in the same age range.

To participate, women need to be 60 years or older, have a life expectancy of at least one year, and be able to understand and sign a consent form. Participants will undergo tests to assess their thinking skills and may also receive brain imaging. It's important to note that women with certain medical conditions or a history of major psychiatric disorders may not be eligible for the trial. Overall, this study aims to shed light on how chemotherapy impacts the brain and cognition in older breast cancer patients, helping to improve care and support for those affected.

Gender

FEMALE

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