Neuroplasticity-Based Cognitive Remediation for Chemotherapy-Related Cognitive Impairment

October 4, 2021 updated by: Paul Newhouse, Vanderbilt University Medical Center
The investigators propose to apply neuroplasticity-based computerized cognitive remediation (nCCR) to treat chemotherapy-related cognitive impairment (CRCI).

Study Overview

Detailed Description

Advances in cancer treatment are producing a growing number of cancer survivors; therefore, issues surrounding quality of life during and following cancer treatment have become increasingly important. Chemotherapy-related cognitive impairment (CRCI) is one such quality of life issue that is commonly reported following chemotherapy treatment in adults. Although studies reporting cognitive impairments associated with chemotherapy have been reported since the 1980s, the phenomenon commonly referred to as 'chemo brain' or 'chemo fog' is poorly understood, and for some patients becomes the most distressful survivorship issue faced. Studies suggest that while up to up to 75% exhibit cognitive decline during treatment, many patients will return to their pre-chemo level of functioning 1 year after completing treatment. However, for 30-35% of cancer patients, their cognitive issues persist.

Studies suggest that this persistent chemotherapy-related cognitive impairment (pCRCI) can remain for months to years after completing treatment, which may have implications for the trajectory of how both normal cognitive aging occurs, but also the risk of cognitive disorders such as Alzheimer's disease, for the growing number of long-term cancer survivors. These concerns are particularly relevant for older individuals as risk for not only cancer, but cognitive impairment (such as dementia) increases with age. As of January 2016, 62% of cancer survivors (9.61 million) are currently 65 years or older, and this number is expected to increase dramatically over the coming decades. Therefore, as the number of older cancer survivors who have will have to cope with pCRCI is likely to increase, it is crucial that The investigators understand the cognitive impairments, the impact on survivors' functioning, and develop treatments for pCRCI.

The investigators propose to target cognitive deficit in CRCI using a novel cognitive enhancement strategy. Our choice of cognitive focus is informed by clinical, behavioral and neurobiological data suggesting a reliable association between cognitive control deficits (CCD), damage to the cognitive control network (CCN), and decline in cognitive functioning. The CCN is a neural network that supports important cognitive control functions such as alerting and orienting attention, response selection, cognitive flexibility, strategy generation, and inhibition of prepotent responses. The investigators propose to apply neuroplasticity-based computerized cognitive remediation (nCCR) to the treatment of CRCI as it has demonstrated training and transfer effects of enhanced CCN function in a similar, abnormally aging population. The theory guiding neuroplasticity-based cognitive interventions is that network abnormalities associated with negative disease-specific clinical outcomes can be altered through the induction of neuroplasticity (even in the aging brain) resulting in enhanced functioning of the target network, and symptomatic improvements.

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Tennessee
      • Nashville, Tennessee, United States, 37212
        • Vanderbilt University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  1. Inclusion Criteria:

    All participants will:

    1. Be between 35 and 80 years of age,
    2. Have been diagnosed with noninvasive or invasive (Stage 1, 2, or 3A) breast cancer, colon cancer, lymphoma, endometrial cancer or ovarian cancer
    3. Have undergone treatment with systemic chemotherapy within the last 1-8 years,
    4. Endorse persistent CRCI subjective complaints (as defined below),
    5. Have no active cardiac, neurologic, or psychiatric illness,
    6. Fluent in and able to read English.
  2. Exclusion Criteria:

Participants will be excluded for:

  1. Any active neurologic psychiatric disease, clinically significant cognitive impairment or dementia, history of significant head trauma followed by persistent neurologic deficits, or known structural brain abnormalities,
  2. Current major depression or another major psychiatric disorder as described in DSM-5 (use of CNS active medications (e.g. antidepressants) will be permitted, provided dosing has been stable for at least 3 months),
  3. Any history of alcohol or substance abuse or dependence within the past 2 years (DSM-5 criteria),
  4. Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the protocol.
  5. Use of any investigational drugs within 30 days or 5 half-lives, whichever is longer, prior to screening, and
  6. Use of cholinergic agents will be discouraged but will be reviewed on a case-by-case basis by the PI.
  7. Red-green color blindness. Other types of color blindness will be reviewed on a case-by-case basis by the PI.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Neuroplasticity-based Computerized Cognitive Remediation
Participants will receive a 45-hour of 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate completion rates of nCCR
Time Frame: 2 years
Assess the percentage of enrolled participants who completed of the 40-hour nCCR treatment
2 years
Evaluate visit frequency throughout nCCR treatment
Time Frame: through study completion, an average of 5 weeks.
Assess the frequency of visits during nCCR treatment
through study completion, an average of 5 weeks.
Evaluate visit duration throughout nCCR treatment
Time Frame: through study completion, an average of 5 weeks.
Assess the duration of visits during nCCR treatment
through study completion, an average of 5 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 17, 2020

Primary Completion (Actual)

June 30, 2021

Study Completion (Actual)

June 30, 2021

Study Registration Dates

First Submitted

January 10, 2020

First Submitted That Met QC Criteria

January 13, 2020

First Posted (Actual)

January 18, 2020

Study Record Updates

Last Update Posted (Actual)

October 5, 2021

Last Update Submitted That Met QC Criteria

October 4, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cancer Survivors

Clinical Trials on Neuroplasticity-based Computerized Cognitive Remediation

Subscribe