Using brain training to help with chemotherapy-related cognitive impairment
Neuroplasticity-Based Cognitive Remediation for Chemotherapy Related Cognitive Impairment Randomized Study
This study is testing a brain training program to see if it can help breast cancer survivors improve their thinking skills affected by chemotherapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 35 Years to 80 Years |
| Sex | All |
| Sponsor | Vanderbilt University Medical Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Nashville, Tennessee) |
| Trial ID | NCT05283629 on ClinicalTrials.gov |
What this trial studies
This study aims to apply a neuroplasticity-based computerized cognitive remediation (nCCR) program to treat chemotherapy-related cognitive impairment (CRCI) in breast cancer survivors. As more patients survive breast cancer, addressing the cognitive side effects of chemotherapy, often referred to as 'chemobrain,' has become crucial for improving their quality of life. The program focuses on enhancing executive functions, which are critical for planning and organization, through targeted brain training exercises. Participants will be monitored for improvements in cognitive function and overall well-being.
Who should consider this trial
Good fit: Ideal candidates are breast cancer survivors aged 35 to 80 who have undergone chemotherapy within the last 1-8 years and report persistent cognitive complaints.
Not a fit: Patients with active neurological or psychiatric conditions, significant cognitive impairment, or unstable medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve cognitive function and quality of life for breast cancer survivors experiencing CRCI.
How similar studies have performed: Previous studies have shown promise in using neuroplasticity-based interventions for cognitive impairments, suggesting potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Nashville, Tennessee
- Center for Cognitive Medicine at Vanderbilt University — Nashville, Tennessee, United States (Recruiting)
Study contacts
- Study coordinator: Nicole T Nguyen, MA
- Email: nicole.tp.nguyen@vumc.org
- Phone: (615) 327-7030
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.