nCCR for Chemotherapy Related Cognitive Impairment Randomized Study

Chemo-brain Clinical Trial

Official title:

Neuroplasticity-Based Cognitive Remediation for Chemotherapy Related Cognitive Impairment Randomized Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05283629
• Other study ID #: 211521
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: March 1, 2025

Study information

• Verified date: June 2024
• Source: Vanderbilt University Medical Center
• Contact: Nicole T Nguyen, MA
• Phone: (615) 327-7030
• Email: nicole.tp.nguyen[@]vumc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 1, 2025
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chemo-brain
• Chemotherapy-Related Cognitive Impairment
• Cognitive Dysfunction

Intervention

Behavioral:
• Neuroplasticity-based Computerized Cognitive Remediation
Behavioral: Neuroplasticity-based Computerized Cognitive Remediation The nCCR has two major components: Bottom up and Top down training. Bottom up" training: The training includes selected tasks from "Brain HQ", a program designed for older adults, that enhances basic processing of sensory stimuli with the goal to improve fidelity of auditory and visual encoding. Top down training": We designed programs to target cognitive control functions associated with poor treatment response, i.e., initiation and use of verbal strategy and susceptibility to interference. These "Top Down" Programs include a visual attention program, either Catch the Ball or Neurogrow, and a semantic strategy program, Semantic Organization.
• Education Control Condition
The education control condition is a learning-based approach that utilizes DVDs on history, art, science, etc. This active condition is comparable to nCCR in length of exposure, audio-visual presentation, computer use and contact with research staff.

Locations

Country	Name	City	State
United States	Center for Cognitive Medicine at Vanderbilt University	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess whether nCCR training produces change in subjective cognitive complaints breast cancer survivors with CRCI.	Paired samples t-tests will be used to assess FACT-Cog PCI Scores. We hypothesize that nCCR treatment will improve FACT-Cog scores in breast cancer patients with persistent CRCI over 6 weeks of treatment compared to the education control group.; The primary measure used to assess subjective cognitive performance was the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) scale and evaluates memory, concentration, mental acuity, verbal fluency, functional interference, and multitasking ability. At baseline and post-treatment visits, participants rated on a 5-point Likert scale how they assessed various aspects of their cognitive functioning over the last 7 days. Higher scores indicate better ratings of cognitive functioning. Higher scores indicate better ratings of cognitive functioning.	6-weeks
Secondary	Assess whether 6-weeks of nCCR training produces change in cognitive performance on neuropsychological measures in breast cancer survivors with CRCI.	Paired samples t-tests will be used to assess Trail Making Test performance. We hypothesize that nCCR treatment will improve Trail Making Test performance in breast cancer patients with persistent CRCI over 6 weeks of treatment compared to the education control group.; The Trail Making Test (TMT) is widely used in both research and clinical settings as a test of some aspects of executive function. Subtracting TMT A completion time from that of TMT B (TMT B-A) is thought to allow the relative contributions of visual search and psychomotor speed to be parsed from the more complex executive functions (such as cognitive flexibility) required to alternate between numbers and letters. Lower scores indicated better cognitive functioning.	6-weeks