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NCT Number: NCT02290834

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

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

Recruiting

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Key information

Age range

60 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital, Boston, Massachusetts, United States

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About this study

  • 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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive, functional and subjective assessments

Other

Cognitive and functional assessments

MRI

Device

Magnetic Resonance Imaging (MRI) Scan

PET Scan

Radiation

Positron Emission Tomography (PET) Scan

Primary outcomes

  1. Change in cognitive performance scores

    Time frame: Baseline, immediately after completion of chemo, and 6 months after completion of chemotherapy

Secondary outcomes

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

    Time frame: Baseline, 6 months after completion of chemotherapy

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

    Time frame: Baseline, 6 months after completion of chemotherapy

  3. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Michael W Parsons, PhD

CONTACT

[email protected]

617-643-0282

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Important dates

Study start
2015
Primary completion
2028
Study completion
2028
First posted
Nov 14, 2014
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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