Clinical trial NCT05283629: nCCR for Chemotherapy Related Cognitive Impairment Randomized Study
Official title: Neuroplasticity-Based Cognitive Remediation for Chemotherapy Related Cognitive Impairment Randomized Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chemo-brain
Chemotherapy-Related Cognitive Impairment
Keywords: Chemotherapy
Cognitive Impairment
neuroplasticity-based computerized cognitive remediation
nCCR
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: University of Utah
First posted: 2022-03-17
Enrollment: 20
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

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.

Primary outcomes:
measure: Assess whether nCCR training produces change in subjective cognitive complaints breast cancer survivors with CRCI.
timeFrame: 6-weeks
Secondary outcomes:
measure: Assess whether 6-weeks of nCCR training produces change in cognitive performance on neuropsychological measures in breast cancer survivors with CRCI.
timeFrame: 6-weeks
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Center for Cognitive Medicine at Vanderbilt University
state: Tennessee
Study officials:
References: