[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100231453":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":40,"centralContacts":44,"locations":50,"responsibleParty":83,"collaborators":29,"id":86,"slug":87,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":90,"acronym":29,"eligibilityCriteria":91,"healthyVolunteers":92,"sex":93,"minAge":94,"maxAge":29,"enrollmentInfo":95,"targetDuration":29,"studyType":98,"phases":99,"briefSummary":101,"conditions":102,"keywords":106,"overallStatus":52,"whyStopped":29,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"Massachusetts General Hospital","OTHER",[8,16,20],{"label":9,"type":10,"description":11,"interventionNames":12},"ARM 1","ACTIVE_COMPARATOR","Breast cancer patients treated with chemotherapy\n\n* Cognitive, functional and subjective assessments (Pre and Post Treatment)\n* Imaging (Pre and Post Treatment)\n\n  * Magnetic Resonance Imaging (MRI) Scan\n  * Magnetic Resonance Imaging (MRI) Scan \u002F Positron Emission Tomography (PET) Scan",[13,14,15],"Other: Cognitive, functional and subjective assessments","Device: MRI","Radiation: PET Scan",{"label":17,"type":10,"description":18,"interventionNames":19},"ARM 2","Non-treated breast cancer patient control\n\n* Cognitive, functional and subjective assessments (Post enrollment and 6-14 months later\n* Imaging (Post Enrollment and at 8-14 months later)\n\n  * Magnetic Resonance Imaging (MRI) Scan\n  * Magnetic Resonance Imaging (MRI) Scan \u002F Positron Emission Tomography (PET) Scan",[13,14,15],{"label":21,"type":10,"description":22,"interventionNames":23},"ARM 3","Healthy control subjects\n\n* Cognitive, functional and subjective assessments (Post enrollment and 6-14 months later\n* Imaging (Post Enrollment and at 8-14 months later)\n\n  * Magnetic Resonance Imaging (MRI) Scan\n  * Magnetic Resonance Imaging (MRI) Scan \u002F Positron Emission Tomography (PET) Scan",[13,14,15],[25,30,35],{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"Cognitive, functional and subjective assessments","Cognitive and functional assessments",[9,17,21],null,{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":29},"DEVICE","MRI","Magnetic Resonance Imaging (MRI) Scan",[9,17,21],{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":29},"RADIATION","PET Scan","Positron Emission Tomography (PET) Scan",[9,17,21],[41],{"name":42,"affiliation":5,"role":43},"Michael Parsons, PhD","PRINCIPAL_INVESTIGATOR",[45],{"name":46,"role":47,"phone":48,"phoneExt":29,"email":49},"Michael W Parsons, PhD","CONTACT","617-643-0282","mwparsons@mgh.harvard.edu",[51,68],{"facility":5,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"RECRUITING","Boston","Massachusetts","02114","United States","US",{"type":59,"coordinates":60},"Point",[61,62],-71.05977,42.35843,{"lat":62,"lon":61},[65,67],{"name":42,"role":47,"phone":48,"phoneExt":29,"email":66},"MWPARSONS@mgh.harvard.edu",{"name":42,"role":43,"phone":29,"phoneExt":29,"email":29},{"facility":69,"status":52,"city":70,"state":54,"zip":71,"country":56,"countryCode":57,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"Massachusetts General Hospital\u002FNorth Shore Cancer Center","Salem","01970",{"type":59,"coordinates":73},[74,75],-70.89552,42.51977,{"lat":75,"lon":74},[78,82],{"name":79,"role":47,"phone":80,"phoneExt":29,"email":81},"Therese Mulvey, MD","678-882-6060","TMMULVEY@PARTNERS.ORG",{"name":79,"role":43,"phone":29,"phoneExt":29,"email":29},{"type":43,"investigatorFullName":84,"investigatorTitle":85,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"Michael W Parsons","Principal Investigator","100231453","chemotherapy-induced-cognitive-and-brain-changes-in-older-adults-with-breast-cancer-100231453",false,"NCT02290834","Chemotherapy-induced Cognitive and Brain Changes in Older Adults With Breast Cancer","Inclusion Criteria:\n\n* Breast cancer patients treated with chemotherapy- Group 1 (experimental group)\n\n  * Participants must meet the following criteria on screening examination to be eligible to participate in the behavioral +\u002F- imaging components of study\n  * New diagnosis histologically confirmed invasive breast cancer\n  * Treatment plan to include chemotherapy\n  * Female subjects age ≥ 60 years.\n  * Life expectancy ≥ 1 year\n  * Karnofsky Performance Score (KPS) ≥ 80\n  * Ability to understand and the willingness to sign a written informed consent document.\n* Non-treated breast cancer patient controls- Group 2 (control group)\n\n  * Participants must meet the following criteria on screening examination to be eligible to participate in the behavioral +\u002F- imaging components of study:\n  * New diagnosis histologically confirmed invasive breast cancer\n  * Treatment plan does not include chemotherapy\n  * Age ≥ 60 years.\n  * Life expectancy ≥ 1 year\n  * Karnofsky Performance Score (KPS) ≥ 80\n  * Ability to understand and the willingness to sign a written informed consent document.\n* Healthy control subjects- Group 3 (control group)\n\n  * Participants must meet the following criteria on screening examination to be eligible to participate in the behavioral +\u002F- imaging components of study:\n  * Age ≥ 60 years.\n  * Life expectancy ≥ 1 year\n  * Karnofsky Performance Score (KPS) ≥ 80\n  * Ability to understand and the willingness to sign a written informed consent document.\n  * Participants with well-controlled vascular risk factors, such as treated hypertension, treated hyperlipidemia or well-controlled Type II diabetes (glucose levels \\\u003C250) may be included.\n  * 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.\n\nExclusion Criteria:\n\n* Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study:\n\n  * Participants with clinical or radiographic evidence of metastatic CNS disease\n  * Subjects with MMSE scores below 24\n  * 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).\n  * Substance abuse within the past 2 years\n  * Huntington's disease, hydrocephalus or seizure disorder\n* 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:\n\n  * Participants with contraindications to MRI (i.e., implanted metal including pacemakers, cerebral spinal fluid shunts, aneurysm clips, artificial heart valves, ear implants or metal\u002Fforeign 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",true,"FEMALE","60 Years",{"count":96,"type":97},200,"ESTIMATED","INTERVENTIONAL",[100],"NA","This research study evaluates the effect of chemotherapy on cognition (thinking) and the brain in people with breast cancer.",[103,104,105],"Impaired Cognition","Chemo-brain","Breast Cancer",[107,104],"Chemotherapy related cognitive impairment","2026-03-09",{"date":110,"type":111},"2026-03-11","ACTUAL",{"date":113,"type":29},"2015-03",{"date":115,"type":97},"2028-01",{"name":5,"class":6},2]