Trial NCT02290834
Chemotherapy-induced Cognitive and Brain Changes in Older Adults With Breast Cancer
- Phase
- Not given
- Sponsor
- Massachusetts General Hospital
- Conditions
- Impaired Cognition; Chemo-brain; Breast Cancer
- Ages
- 60+ years
Eligibility criteria
Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).
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) ≥ 80Performance status
* 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.Pregnancy
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 diseaseBrain metastases
* 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
Restrictions found (3)
- Brain metastasesOutrightexclusionShow in the text
- Performance statusOutrightinclusion
KPS ≥ 80
Show in the text - PregnancyConditionalinclusionShow in the text
Recruiting in Massachusetts
- Massachusetts General Hospital · Boston, Suffolk County
- Massachusetts General Hospital/North Shore Cancer Center · Salem, Essex County