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New treatment option for Impaired Cognition
Official title Chemotherapy-induced Cognitive and Brain Changes in Older Adults With Breast Cancer
ClinicalTrials.gov ID: NCT02290834
What this study is testing
- What it's testing
- This research study evaluates the effect of chemotherapy on cognition (thinking) and the brain in people with breast cancer.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 and older, women only. Healthy volunteers may be eligible.
You may be able to join if
- 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 people age ≥ 60 years.
You likely can't join if
- 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
- people 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...
- Substance abuse within the past 2 years
- Huntington's disease, hydrocephalus or seizure disorder
See the full eligibility 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 people 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 people- 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.
- 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
- people 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
- Salem, Massachusetts, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 60 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States; Salem, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.