Recruiting

Observational Study

Sponsor:

Massachusetts General Hospital

Code:

NCT02290834

Conditions

Impaired Cognition

Chemo-brain

Breast Cancer

Eligibility Criteria

Sex: Female

Age: 60+

Healthy Volunteers: Accepted

Interventions

Cognitive, functional and subjective assessments

MRI

PET Scan

Study Details

Brief summary:

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

Conditions

Impaired Cognition

Chemo-brain

Breast Cancer

Study ID

NCT02290834

Start date

Mar, 2015

Status verified date

Jul, 2026

Completion date

Jan, 2028

Anticipated

Primary completion date

Jan, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 60+

Healthy Volunteers: Accepted

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 Design

Enrollment

200 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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

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

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

Interventions

Cognitive, functional and subjective assessments

Cognitive and functional assessments

MRI

Magnetic Resonance Imaging (MRI) Scan

PET Scan

Positron Emission Tomography (PET) Scan

Primary outcome measure

  • Change in cognitive performance scores [ Time Frame: Baseline, immediately after completion of chemo, and 6 months after completion of chemotherapy ]

Central Contacts and Locations

Central contacts

Michael W Parsons, PhD

617-643-0282mwparsons@mgh.harvard.edu

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Michael Parsons, PhD

617-643-0282MWPARSONS@mgh.harvard.edu

Principal Investigator:

Michael Parsons, PhD

Massachusetts General Hospital/North Shore Cancer Center

Recruiting

Salem, Massachusetts, United States, 01970

Contacts

Therese Mulvey, MD

(678) 882-6060TMMULVEY@PARTNERS.ORG

Principal Investigator:

Therese Mulvey, MD

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Jul 16, 2026

Last verified

Jul, 2026

Keywords

  • Chemotherapy related cognitive impairment
  • Chemo-brain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-07-16.