Status:
RECRUITING
Chemotherapy-induced Cognitive and Brain Changes in Older Adults With Breast Cancer
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Impaired Cognition
Chemo-brain
Eligibility:
FEMALE
60+ years
Phase:
NA
Brief Summary
This research study evaluates the effect of chemotherapy on cognition (thinking) and the brain in people with breast cancer.
Detailed Description
* 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT02290834
Start Date
March 1 2015
End Date
January 1 2027
Last Update
December 9 2025
Active Locations (2)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Massachusetts General Hospital/North Shore Cancer Center
Salem, Massachusetts, United States, 01970