Neuroplasticity-Based Cognitive Remediation for Chemotherapy-Related Cognitive Impairment
Neuroplasticity-Based Cognitive Remediation for Chemotherapy-Related Cognitive Impairment
Sponsors
Source
Vanderbilt University Medical Center
Oversight Info
Has Dmc
No
Is Fda Regulated Drug
No
Is Fda Regulated Device
No
Brief Summary
The investigators propose to apply neuroplasticity-based computerized cognitive
remediation (nCCR) to treat chemotherapy-related cognitive impairment (CRCI).
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.
Overall Status
Completed
Start Date
2020-02-17
Completion Date
2021-06-30
Primary Completion Date
2021-06-30
Phase
N/A
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
Evaluate completion rates of nCCR |
2 years |
|
Evaluate visit frequency throughout nCCR treatment |
through study completion, an average of 5 weeks. |
|
Evaluate visit duration throughout nCCR treatment |
through study completion, an average of 5 weeks. |
Enrollment
21
Conditions
Intervention
Intervention Type
Behavioral
Intervention Name
Description
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.
Arm Group Label
Neuroplasticity-based Computerized Cognitive Remediation
Eligibility
Criteria
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.
Gender
All
Minimum Age
35 Years
Maximum Age
80 Years
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
Paul A Newhouse, MD |
Principal Investigator |
Vanderbilt University Medical Center |
Location
Facility |
|
Vanderbilt University Medical Center Nashville 4644585 Tennessee 4662168 37212 United States |
Location Countries
Country
United States
Verification Date
2021-10-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Principal Investigator
Investigator Affiliation
Vanderbilt University Medical Center
Investigator Full Name
Paul Newhouse
Investigator Title
MD, Principal Investigator
Keywords
Has Expanded Access
No
Condition Browse
Number Of Arms
1
Arm Group
Arm Group Label
Neuroplasticity-based Computerized Cognitive Remediation
Arm Group Type
Experimental
Description
Participants will receive a 45-hour of Neuroplasticity-based Computerized Cognitive
Remediation.
Firstreceived Results Date
N/A
Patient Data
Sharing Ipd
No
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
A single-arm, open label design; All analyses are pre-post, with participants serving as
their own controls.
Primary Purpose
Treatment
Masking
None (Open Label)
Study First Submitted
January 10, 2020
Study First Submitted Qc
January 13, 2020
Study First Posted
January 18, 2020
Last Update Submitted
October 4, 2021
Last Update Submitted Qc
October 4, 2021
Last Update Posted
October 5, 2021
ClinicalTrials.gov processed this data on October 31, 2025
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.