Chemotherapy Effects on Thinking in Older Women with Breast Cancer
Chemotherapy-induced Cognitive and Brain Changes in Older Adults With Breast Cancer
Recruiting
N/AInterventional Study
Impaired CognitionChemo-brainBreast Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
60 and older
Sex
Female
Study type
Interventional
Purpose
Diagnostic
Participants needed
200 (estimated)
Sponsor
Massachusetts General Hospital · Other
Who this trial is looking for
This trial is looking for women aged 60 and older who have been diagnosed with breast cancer. Participants will help researchers understand how chemotherapy affects thinking and brain function.
Are You a Good Fit for This Trial?
You may be able to join if
I am a woman aged 60 or older.
I have been diagnosed with invasive breast cancer.
I will be treated with chemotherapy.
I expect to live for at least 1 more year.
I have a Karnofsky Performance Score of 80 or higher.
I can understand and sign a consent form.
You may not be able to join if
I have signs of cancer spread to the brain.
I have a memory score (MMSE) below 24.
I have a history of severe mental disorders.
I have abused substances in the past 2 years.
I have Huntington's disease or a seizure disorder.
I have metal implants that make me unsuitable for MRI.
I have had eye injuries from metal without proof of removal.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
This research study evaluates the effect of chemotherapy on cognition (thinking) and the brain in people with breast cancer.
Trial Locations
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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…
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
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