RECRUITING

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

Conditions

Impaired Cognition Chemo-brain Breast Cancer Chemotherapy related cognitive impairment

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2015-03

Study Completion:2027-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT02290834

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.

Ages Eligible for Study:60 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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

Inclusion Criteria

Exclusion 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.

* 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

Study Contact

Edwin Nunez

CONTACT

617-643-4395

ENUNEZ2@partners.org

Principal Investigator

Michael Parsons, PhD

PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Study Locations (Sites)

Massachusetts General Hospital

Boston, Massachusetts, 02114

United States

Massachusetts General Hospital/North Shore Cancer Center

Salem, Massachusetts, 01970

United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

Michael Parsons, PhD, PRINCIPAL_INVESTIGATOR, 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 Registration Dates

Study Start Date2015-03

Study Completion Date2027-01

Study Record Updates

Study Start Date2015-03

Study Completion Date2027-01

Terms related to this study

Keywords Provided by Researchers

Chemotherapy related cognitive impairment
Chemo-brain

Additional Relevant MeSH Terms

Impaired Cognition
Chemo-brain
Breast Cancer