Status:
ACTIVE_NOT_RECRUITING
nCCR for Chemotherapy Related Cognitive Impairment Randomized Study
Lead Sponsor:
University of Massachusetts, Worcester
Collaborating Sponsors:
University of Utah
Vanderbilt University Medical Center
Conditions:
Chemo-brain
Chemotherapy-Related Cognitive Impairment
Eligibility:
All Genders
35-80 years
Phase:
NA
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 can...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2030
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05283629
Start Date
August 1 2022
End Date
March 1 2030
Last Update
January 8 2026
Active Locations (1)
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1
UMass Chan Medical School
Worcester, Massachusetts, United States, 01655