Breast Cancer Clinical Trial

nCCR for Chemotherapy Related Cognitive Impairment Randomized Study

Summary

The investigators propose to apply neuroplasticity-based computerized cognitive remediation (nCCR) to treat chemotherapy-related cognitive impairment (CRCI).

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Full Description

Successes in breast cancer treatment are resulting in a growing number of cancer survivors. This has broadened the scope of care from treating the disease alone to improving the quality of life of cancer survivors. Chemotherapy-related cognitive impairment (CRCI), often referred to by patients as 'chemobrain,' is a common and highly distressful side effect of chemotherapy often reported by breast cancer survivors. Managing the symptoms of CRCI should be integrated with routine cancer care as these symptoms diminish quality of life, impair work performance, and make it more difficult for patients to follow treatment regimens. CRCI can persist for months to years following cancer treatment. However, there are currently no established treatments for CRCI.

The most commonly reported CRCI symptoms in breast cancer survivors include problems with executive functions. Executive function is a cognitive domain involved in planning, problem-solving, organization, and time management. In order to improve executive dysfunction and quality of life in breast cancer survivors, we propose to use a new brain training program called neuroplasticity-based computerized cognitive remediation (nCCR). The term 'neuroplasticity' refers to the brain's ability to modify, change, and adapt throughout life and in response to experience. Neuroplacticity can be induced through the use of focused brain training that nCCR offers. Past work demonstrates that this neuroscience-guided brain training benefits other patient populations with similar cognitive problems and has shown preliminary success in cancer survivors in a small pilot study. If successful, this treatment could have significant benefits for large numbers of breast cancer survivors.

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Eligibility Criteria

Inclusion Criteria:

All participants will:

between 35 and 80 years of age
have been diagnosed with noninvasive or invasive breast cancer
have undergone treatment with systemic chemotherapy within the last 1- 8 years
endorse persistent CRCI subjective complaints
have no active unstable medical condition
fluent in and able to read English.

Exclusion Criteria:

Participants will be excluded for

any active neurologic or untreated/non-remitted psychiatric disease, (e.g. active major depression or another major psychiatric disorder as described in DSM-5)
clinically significant cognitive impairment identified on cognitive screening, diagnosis of mild cognitive impairment or dementia
history of significant head trauma followed by persistent neurologic deficits
history of alcohol or substance abuse or dependence within the past 2 years (DSM-5 criteria)
any significant systemic illness or unstable medical condition which could lead to difficulty complying with the protocol
Use of any investigational drugs within 30 days or 5 half-lives, whichever is longer, prior to screening
red-green color blindness
Use of certain CNS active medications (e.g. antidepressants) will be permitted, provided dosing has been stable for at least 3 months.

Study is for people with:

Breast Cancer

Estimated Enrollment:

16

Study ID:

NCT05283629

Recruitment Status:

Recruiting

Sponsor:

Vanderbilt University Medical Center

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There is 1 Location for this study

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Center for Cognitive Medicine at Vanderbilt University
Nashville Tennessee, 37212, United States More Info
Soniya N Patel, BA
Contact
615-936-6567
[email protected]
Jennifer N Vega, PhD
Principal Investigator
Paul A Newhouse, MD
Sub-Investigator
Sarah S Morimoto, PsyD
Sub-Investigator

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

16

Study ID:

NCT05283629

Recruitment Status:

Recruiting

Sponsor:


Vanderbilt University Medical Center

How clear is this clinincal trial information?

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