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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 60 Years and Over
Gender Female
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02290834
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Massachusetts General Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Michael Parsons, PhD
Principal Investigator Affiliation Massachusetts General Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Impaired Cognition, Chemo-brain, Breast Cancer
Additional Details

  • - 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

Arms & Interventions

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

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Massachusetts General Hospital, Boston, Massachusetts

Status

Recruiting

Address

Massachusetts General Hospital

Boston, Massachusetts, 02114

Site Contact

Michael Parsons, PhD

[email protected]

617-643-0282

Salem, Massachusetts

Status

Recruiting

Address

Massachusetts General Hospital/North Shore Cancer Center

Salem, Massachusetts, 01970

Site Contact

Therese Mulvey, MD

[email protected]

678-882-6060

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