Chemotherapy-induced Cognitive and Brain Changes in Older Adults With Breast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age60+
SponsorMassachusetts General Hospital
About this trial
This research study evaluates the effect of chemotherapy on cognition (thinking) and the brain in people with breast cancer.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Cognitive, functional and subjective assessments
Other interventionCognitive and functional assessments
MRI
DeviceMagnetic Resonance Imaging (MRI) Scan
PET Scan
RadiationPositron Emission Tomography (PET) Scan
Treatment groups
200 Participants
are divided into 3 treatment groupsGroup A: ARM 1Active comparator 3 interventions
Group B: ARM 2Active comparator 3 interventions
Group C: ARM 3Active comparator 3 interventions
Trial outcomes
Primary outcomes
1
Change in cognitive performance scores
Time frame
Baseline, immediately after completion of chemo, and 6 months after completion of chemotherapySecondary outcomes
1
Correlation between baseline amyloid accumulation in the brain and change in cognitive performance
Time frame
Baseline, 6 months after completion of chemotherapy2
Correlation between baseline tau accumulation in the brain and change in cognitive performance
Time frame
Baseline, 6 months after completion of chemotherapy3
Correlation between change in tau accumulation in the brain (from baseline to 6 months after completion of chemotherapy) and change in cognitive performance (from baseline to 6 months after completion of chemotherapy)
Time frame
Baseline, 6 months after completion of chemotherapySponsors and contacts
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Source ClinicalTrials.gov