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Chemotherapy-induced Cognitive and Brain Changes in Older Adults With Breast Cancer | Clinical Trials | Clareo Health

RECRUITINGNA

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

NCT02290834•Massachusetts General Hospital

Summary

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

Detailed Description

* This study is being done to study effects of chemotherapy (cancer treatment) on the brain and cognition (thinking). "Chemo-brain" is a term sometimes used to refer to effects of chemotherapy on the brain and cognition (thinking). * This study is being done to test for "chemo-brain" in older adults with breast cancer treated with chemotherapy, and to identify people who are most likely to be affected. The investigators will look at thinking abilities and brain images before and after chemotherapy to see if it can help identify people at risk for cognitive side effects of the treatment, and to better understand effects of treatment on brain structure and function. * The investigators are looking for participants who have either been recently recently diagnosed breast cancer participant or a healthy volunteer. * What is involved in the study: * Memory and Thinking Tests * Imaging: Either MRI/or MRI and PET Scans

Eligibility

Age

60 - No limit years

Sex

FEMALE

Healthy Volunteers

Yes

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:
+14 more criteria

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
•* 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

Locations (2)

Massachusetts General Hospital

Boston, Massachusetts, United States

Massachusetts General Hospital/North Shore Cancer Center

Salem, Massachusetts, United States

Key Dates

Start Date

March 1, 2015

Primary Completion Date

January 1, 2028

Completion Date

January 1, 2028

Last Updated

March 11, 2026

Enrollment

200

ESTIMATED participants

Conditions

Impaired CognitionChemo-brainBreast Cancer

Interventions

Cognitive, functional and subjective assessments

OTHER

MRI

DEVICE

PET Scan

RADIATION

Contacts

Michael W Parsons, PhD

CONTACT

617-643-0282 mwparsons@mgh.harvard.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 11, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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