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

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ClinicalTrials.gov Identifier: NCT02290834
Recruitment Status : Unknown
Verified January 2021 by Michael W Parsons, Massachusetts General Hospital.
Recruitment status was:  Recruiting
First Posted : November 14, 2014
Last Update Posted : January 20, 2021
Sponsor:
Information provided by (Responsible Party):
Michael W Parsons, Massachusetts General Hospital

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

Condition or disease Intervention/treatment Phase
Impaired Cognition Chemo-brain Breast Cancer Other: Cognitive, functional and subjective assessments Device: MRI Radiation: PET Scan Not Applicable

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
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Chemotherapy-induced Cognitive and Brain Changes in Older Adults With Breast Cancer
Study Start Date : March 2015
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: ARM 1

Breast cancer patients treated with chemotherapy

  • Cognitive, functional and subjective assessments (Pre and Post Treatment)

  • Imaging (Pre and Post Treatment)

    • Magnetic Resonance Imaging (MRI) Scan
    • Magnetic Resonance Imaging (MRI) Scan / Positron Emission Tomography (PET) Scan
 Other: Cognitive, functional and subjective assessments
Cognitive and functional assessments

Device: MRI
Magnetic Resonance Imaging (MRI) Scan

Radiation: PET Scan
Positron Emission Tomography (PET) Scan
Active Comparator: ARM 2

Non-treated breast cancer patient control

  • Cognitive, functional and subjective assessments (Post enrollment and 6-14 months later

  • Imaging (Post Enrollment and at 8-14 months later)

    • Magnetic Resonance Imaging (MRI) Scan
    • Magnetic Resonance Imaging (MRI) Scan / Positron Emission Tomography (PET) Scan
 Other: Cognitive, functional and subjective assessments
Cognitive and functional assessments

Device: MRI
Magnetic Resonance Imaging (MRI) Scan

Radiation: PET Scan
Positron Emission Tomography (PET) Scan
Active Comparator: ARM 3

Healthy control subjects

  • Cognitive, functional and subjective assessments (Post enrollment and 6-14 months later

  • Imaging (Post Enrollment and at 8-14 months later)

    • Magnetic Resonance Imaging (MRI) Scan
    • Magnetic Resonance Imaging (MRI) Scan / Positron Emission Tomography (PET) Scan
 Other: Cognitive, functional and subjective assessments
Cognitive and functional assessments

Device: MRI
Magnetic Resonance Imaging (MRI) Scan

Radiation: PET Scan
Positron Emission Tomography (PET) Scan


Outcome Measures
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Primary Outcome Measures :
  1. Change in cognitive performance scores [ Time Frame: Baseline, immediately after completion of chemo, and 6 months after completion of chemotherapy ]

Secondary Outcome Measures :
  1. Correlation between baseline amyloid accumulation in the brain and change in cognitive performance [ Time Frame: Baseline, 6 months after completion of chemotherapy ]
  2. Correlation between baseline tau accumulation in the brain and change in cognitive performance [ Time Frame: Baseline, 6 months after completion of chemotherapy ]
  3. 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 chemotherapy ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02290834


Contacts
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Contact: Edwin Nunez 617-643-4395 ENUNEZ2@partners.org

Locations
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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Michael Parsons, PhD    617-643-0282    MWPARSONS@mgh.harvard.edu   
Principal Investigator: Michael Parsons, PhD         
Massachusetts General Hospital/North Shore Cancer Center Recruiting
Salem, Massachusetts, United States, 01970
Contact: Therese Mulvey, MD    678-882-6060    TMMULVEY@PARTNERS.ORG   
Principal Investigator: Therese Mulvey, MD         
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Michael Parsons, PhD Massachusetts General Hospital
More Information
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Responsible Party: Michael W Parsons, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02290834    
Other Study ID Numbers: 14-217
First Posted: November 14, 2014    Key Record Dates
Last Update Posted: January 20, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: No data are yet available
Keywords provided by Michael W Parsons, Massachusetts General Hospital:
Chemotherapy related cognitive impairment
Chemo-brain
Additional relevant MeSH terms:
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Breast Neoplasms
Cognitive Dysfunction
Neoplasms by Site
Neoplasms
Breast Diseases
 Skin Diseases
Cognition Disorders
Neurocognitive Disorders
Mental Disorders