RecruitingNot ApplicableNCT02290834

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

Sponsor

Massachusetts General Hospital

Enrollment

200 participants

Start Date

Mar 1, 2015

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Chemo-brain Impaired Cognition

Summary

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

Eligibility

Sex: FEMALEMin Age: 60 Years

Inclusion Criteria24

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 Criteria7

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
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