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.]

NCT02290834 : Chemotherapy-induced Cognitive and Brain Changes in Older Adults With Breast Cancer
PhaseN/A
AgesMin: 60 Years Max: N/A
Eligibility
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
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02290834      |      Link to official Clinicaltrials.gov listing
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