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

Primary Purpose

Impaired Cognition, Chemo-brain, Breast Cancer

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Cognitive, functional and subjective assessments

MRI

PET Scan

About this trial

This is an interventional diagnostic trial for Impaired Cognition focused on measuring Chemotherapy related cognitive impairment, Chemo-brain

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Massachusetts General HospitalRecruiting
Massachusetts General Hospital/North Shore Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

ARM 1

ARM 2

ARM 3

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Change in cognitive performance scores

Secondary Outcome Measures

Correlation between baseline amyloid accumulation in the brain and change in cognitive performance

Correlation between baseline tau accumulation in the brain and change in cognitive performance

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)

Full Information

NCT ID

NCT02290834

First Posted

November 5, 2014

Last Updated

January 19, 2021

Sponsor

Massachusetts General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02290834

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Unknown status

Study Start Date

March 2015 (undefined)

Primary Completion Date

January 2023 (Anticipated)

Study Completion Date

January 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Massachusetts General Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Impaired Cognition, Chemo-brain, Breast Cancer

Keywords

Chemotherapy related cognitive impairment, Chemo-brain

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

ARM 1

Arm Type

Active Comparator

Arm Description

Arm Title

ARM 2

Arm Type

Active Comparator

Arm Description

Arm Title

ARM 3

Arm Type

Active Comparator

Arm Description

Intervention Type

Other

Intervention Name(s)

Cognitive, functional and subjective assessments

Intervention Description

Cognitive and functional assessments

Intervention Type

Device

Intervention Name(s)

MRI

Intervention Description

Magnetic Resonance Imaging (MRI) Scan

Intervention Type

Radiation

Intervention Name(s)

PET Scan

Intervention Description

Positron Emission Tomography (PET) Scan

Primary Outcome Measure Information:

Title

Change in cognitive performance scores

Time Frame

Baseline, immediately after completion of chemo, and 6 months after completion of chemotherapy

Secondary Outcome Measure Information:

Title

Correlation between baseline amyloid accumulation in the brain and change in cognitive performance

Time Frame

Baseline, 6 months after completion of chemotherapy

Title

Correlation between baseline tau accumulation in the brain and change in cognitive performance

Time Frame

Baseline, 6 months after completion of chemotherapy

Title

Time Frame

Baseline, 6 months after completion of chemotherapy

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Edwin Nunez

Phone

617-643-4395

ENUNEZ2@partners.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael Parsons, PhD

Organizational Affiliation

Massachusetts General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Michael Parsons, PhD

Phone

617-643-0282

MWPARSONS@mgh.harvard.edu

First Name & Middle Initial & Last Name & Degree

Michael Parsons, PhD

Facility Name

Massachusetts General Hospital/North Shore Cancer Center

City

Salem

State/Province

Massachusetts

ZIP/Postal Code

01970

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Therese Mulvey, MD

Phone

678-882-6060

TMMULVEY@PARTNERS.ORG

First Name & Middle Initial & Last Name & Degree

Therese Mulvey, MD

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

No data are yet available

Learn more about this trial

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

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