Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT01949376 : Mild Cognitive Impairment in Breast Cancer Patients
PhaseN/A
AgesMin: 40 Years Max: 70 Years
Eligibility
Inclusion Criteria:

- Female, within the age range of 40-70

- Post-menopausal, or will undergo hormonal therapy.

- CH+ patients - any stage of breast cancer without brain metastasis, has undergone
surgery prior to screening, will undergo hormonal therapy with or without
chemotherapy.

- CH- patients - any stage of breast cancer without brain metastasis, has undergone
surgery prior to screening, will undergo no therapy or radiation therapy.

- CON - cognitively normal on the basis of annual neuropsychological and research
neurological examinations done as part of the Uniform Data Set (UDS), of the NIA
Alzheimer's Disease Centers (ADC) program, recruited from the NU CNADC Clinical Core.

- All subjects must have given signed, informed consent prior to registration on study.

Exclusion Criteria:

- Individuals who report significant medical, neurologic, or psychiatric illness,
including but not limited to:

- Major depression

- Schizophrenia

- ADHD

- Autism

- Alzheimer's disease

- Dementia

- Obsessive-compulsive disorder

- Post-traumatic stress disorder

- Individuals with an Inventory of Depressive Symptomatology - Self Report (IDS-SR)
score of 30 or higher, since this level of depression could affect cognitive test
performance.

- Left-handed individuals, as including this population would muddy MRI brain analysis
due to differing lateralization of function between right- and left-handed
individuals

- Brain surgery or head injury

- Individuals reporting previous head injury

- Individuals requiring neurosurgical procedures

- Ineligibility for MRI scanning, including but not limited to:

- Individuals who have non-MRI compatible medical implants or devices

- Individuals who have any potential metal in their bodies

- Individuals who have claustrophobia

- Individuals with permanent makeup

- Individuals reporting consumption of drugs that would affect cognition
(neuropsychiatric or illicit)

- Individuals indicating a history of breast cancer will be excluded from the healthy
control group

- Women entering this study should be post-menopausal. If, however, a woman becomes
pregnant after enrolling in the study, she will be excluded.
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT01949376      |      Link to official Clinicaltrials.gov listing
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