An interventional study of Neurocognitive assessments in Chemotherapy-induced Cognitive Impairment, sponsored by Rachel Miller. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-11-12.
Sponsored by Rachel Miller · Not applicable, Interventional, and Supportive care
Chemotherapy-induced cognitive impairment (CICI), also known as "chemobrain," is a spectrum of neurocognitive deficits experienced during and after the administration of chemotherapy for cancer. The incidence of CICI is significant, affecting anywhere from 25 to 75% of survivors, and the biologic basis is unknown. This novel study is designed to address the questions of incidence and biological cause for CICI, while gaining a better understanding of the structural and functional effects of chemotherapy on the brain.
Chemotherapy-induced cognitive impairment (CICI), also known as "chemobrain," is a spectrum of neurocognitive deficits experienced during and after the administration of chemotherapy for cancer. The incidence of CICI is significant, affecting anywhere from 25 to 75% of survivors, and the biologic basis is unknown. This novel study is designed to address the questions of incidence and biological cause for CICI, while gaining a better understanding of the structural and functional effects of chemotherapy on the brain. In order to address these important objectives, a diverse team of experienced investigators has been assembled to design and implement the proposed protocol. The research team for this project seeks to accomplish the proposed objectives through following mechanisms: 1) assessment of the neurocognitive domains affected in CICI using a tailored battery of cognitive tests to define CICI; 2) measurement of serum markers of oxidative stress and correlation of these markers with neurocognitive test results; and 3) exploration of structural and functional changes in the brain during cognitive tasks and correlation of results with markers of oxidative stress and neurocognitive test results.
39 studies on the registry are indexed under Chemotherapy-Related Cognitive Impairment; 19 are open to participants now.
This study's enrollment of 14 is below the median of 95 across 30 interventional studies indexed under Chemotherapy-Related Cognitive Impairment.
Browse Chemotherapy-Related Cognitive Impairment studies →Rachel Miller is the lead sponsor of 7 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All participants receive pre- and post-chemotherapy neurocognitive assessments. A sequentially-assigned subset also receive pre- and post-chemotherapy Functional Magnetic Resonance Imaging (FMRI) procedures.
Behavioral: Neurocognitive assessments
Baseline and post-chemotherapy neurocognitive testing. A sequentially-assigned subset of participants also receive baseline and post-chemotherapy neuroimaging (FMRI)
Reliable Change Index (RCI)
To address the primary aim, RCI (which is essentially a z-score) for each patient will be calculated from the pre-, post-chemotherapy Montreal Cognitive Assessment (MoCA) test results. Then a Wilcoxon signed rank test will be applied to the RCI values with corresponding 95% confidence intervals.
Time frame: 4 weeks after completing cycle #6 chemotherapy (each cycle is 21 days)
Assess the correlation between biologic markers of oxidative stress and neurocognitive test results.
Analysis of covariance (ANCOVA), adjusting for baseline log serum levels, will be utilized to assess for differences in log levels over timepoints including the 4 and 6 hour samples. Spearman correlations will be utilized to describe associations with cognitive tests scores and biochemical measured in addition to Spearman Correlation coefficients between baseline biochemical measures.
Time frame: 4 weeks after completing cycle #6 chemotherapy (each cycle is 21 days)
Assess the correlation between brain imaging and neurocognitive test results
For neurological outcomes, a longitudinal comparison before and after Chemotherapy in fMRI (percent signal change and extend of activation voxels), DTI (FA % change), and ERP (uV) will be performed. There will be changes in patterns of fMRI responses, FA, and ERP signals from baseline to after treatment. We expect that fMRI activation will be change in prefrontal regions change of effort needed to do the memory task. Changes in white matter FA in after the treatment may be observable in the white matter regions such as the frontal and temporal cortices as well as in gray matter regions suspected to be affected by the Chemo. Cognitive ERP patterns will be changed in the same individuals. fMRI and ERP analysis can be analyzed and compared at individual level. To explore correlations between fMRI outcomes and cognitive measures, ANCOVA is an appropriate choice since we want to study measures after treatment, relative to initial values.
Time frame: 4 weeks after completing cycle #6 chemotherapy (each cycle is 21 days)
Plan to share: No
No publications or documents are linked to this record.
Ran from Aug 2016 to primary completion in Oct 2018, 26 months.
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This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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Rachel Miller