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

March 18, 2024 updated by: Michael W Parsons, Massachusetts General Hospital
This research study evaluates the effect of chemotherapy on cognition (thinking) and the brain in people with breast cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Contact:
        • Principal Investigator:
          • Michael Parsons, PhD
      • Salem, Massachusetts, United States, 01970
        • Recruiting
        • Massachusetts General Hospital/North Shore Cancer Center
        • Principal Investigator:
          • Therese Mulvey, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in cognitive performance scores
Time Frame: Baseline, immediately after completion of chemo, and 6 months after completion of chemotherapy
Baseline, immediately after completion of chemo, and 6 months after completion of chemotherapy

Secondary Outcome Measures

Outcome Measure
Time Frame
Correlation between baseline amyloid accumulation in the brain and change in cognitive performance
Time Frame: Baseline, 6 months after completion of chemotherapy
Baseline, 6 months after completion of chemotherapy
Correlation between baseline tau accumulation in the brain and change in cognitive performance
Time Frame: Baseline, 6 months after completion of chemotherapy
Baseline, 6 months after completion of chemotherapy
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
Baseline, 6 months after completion of chemotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Investigators

  • Principal Investigator: Michael Parsons, PhD, Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

November 5, 2014

First Submitted That Met QC Criteria

November 11, 2014

First Posted (Estimated)

November 14, 2014

Study Record Updates

Last Update Posted (Actual)

March 19, 2024

Last Update Submitted That Met QC Criteria

March 18, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-217

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

No data are yet available

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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