Chemo-brainNCT05283629
nCCR for Chemotherapy Related Cognitive Impairment Randomized Study
A study testing Neuroplasticity-based Computerized Cognitive Remediation in people with Chemo-brain and Chemotherapy-Related Cognitive Impairment, run by University of Massachusetts, Worcester at 1 site in United States.
Trial summary
The investigators propose to apply neuroplasticity-based computerized cognitive remediation (nCCR) to treat chemotherapy-related cognitive impairment (CRCI). Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Chemo-brain, Chemotherapy-Related Cognitive Impairment
- What is being tested?
- Neuroplasticity-based Computerized Cognitive Remediation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2022to 1 Mar 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UMass Chan Medical School
Worcester, Massachusetts, 01655
About this study
Official title: Neuroplasticity-Based Cognitive Remediation for Chemotherapy Related Cognitive Impairment Randomized Study
The investigators propose to apply neuroplasticity-based computerized cognitive remediation (nCCR) to treat chemotherapy-related cognitive impairment (CRCI).
Read the 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 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.
- Being tested
- Neuroplasticity-based Computerized Cognitive Remediation, Active Control Condition
- Keywords
- Chemotherapy, Cognitive Impairment, neuroplasticity-based computerized cognitive remediation, nCCR
- Medical subject headings
- Chemotherapy-Related Cognitive Impairment, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuroplasticity-based Computerized Cognitive RemediationBehavioural
Behavioral: Neuroplasticity-based Computerized Cognitive Remediation Participants will engage in a computerized training program designed to support cognitive health in older adults. The program includes a variety of exercises that target basic sensory processing as well as higher-level cognitive functions. Training tasks adapt in difficulty based on individual performance and are intended to improve information processing and executive skills. Activities are delivered in a structured format and customized to participant progress.
Active Control ConditionBehavioural
The active control condition is a structured, learning-based program designed to match the nCCR intervention in terms of duration, computer use, audiovisual engagement, and participant contact with research staff.
| Study group | Role | What they receive |
|---|---|---|
| Neuroplasticity-based Computerized Cognitive Remediation | Experimental | Behavioral: Neuroplasticity-based Computerized Cognitive Remediation Participants will engage in a computerized training program designed to support cognitive health in older adults. The program includes a variety of exercises that target basic sensory processing as well as higher-level cognitive functions. Training tasks adapt in difficulty based on individual performance and are intended to improve information processing and executive skills. Activities are delivered in a structured format and customized to participant progress. Receives: Behavioral: Neuroplasticity-based Computerized Cognitive Remediation |
| Active Comparison Control | Active comparator | The active control condition is a structured, learning-based program designed to match the nCCR intervention in terms of duration, computer use, audiovisual engagement, and participant contact with research staff. Receives: Behavioral: Active Control Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6-weeks
Secondary outcomes (1)
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.
Measured: 6-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start1 Aug 2022
- Primary completion1 Jun 2029 (estimated)
- Study completion1 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemo-brainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- University of Utah, Vanderbilt University Medical Center
- Responsible party
- Principal investigator, Jennifer Vega, University of Massachusetts, Worcester
- Investigators
- Jennifer N Vega, PhD, Principal investigator, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05283629
- Sponsor's protocol ID
- 211521
- Status last verified
- Jan 2026
- First submitted
- 3 Feb 2022
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroplasticity-Based Cognitive Remediation for Chemotherapy Related Cognitive Impairment Randomized Study
- ClinicalTrials.gov ID
- NCT05283629
- Acronym / sponsor ID
- 211521
- Keywords
- Chemotherapy, Cognitive Impairment, neuroplasticity-based computerized cognitive remediation, nCCR
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- University of Utah, Vanderbilt University Medical Center
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Jun 2029 (estimated)
- Study completion
- 1 Mar 2030 (estimated)
- First posted
- 17 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neuroplasticity-based Computerized Cognitive Remediation | Experimental | Behavioral: Neuroplasticity-based Computerized Cognitive RemediationBehavioral: Neuroplasticity-based Computerized Cognitive Remediation Participants will engage in a computerized training program designed to support cognitive health in older adults. The program includes a variety of exercises that target basic sensory processing as well as higher-level cognitive functions. Training tasks adapt in difficulty based on individual performance and are intended to improve information processing and executive skills. Activities are delivered in a structured format and customized to participant progress. |
| Active Comparison Control | Active comparator | Behavioral: Active Control ConditionThe active control condition is a structured, learning-based program designed to match the nCCR intervention in terms of duration, computer use, audiovisual engagement, and participant contact with research staff. |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuroplasticity-based Computerized Cognitive RemediationBehavioral: Neuroplasticity-based Computerized Cognitive Remediation Participants will engage in a computerized training program designed to support cognitive health in older adults. The program includes a variety of exercises that target basic sensory processing as well as higher-level cognitive functions. Training tasks adapt in difficulty based on individual performance and are intended to improve information processing and executive skills. Activities are delivered in a structured format and customized to participant progress. | Behavioural | Neuroplasticity-based Computerized Cognitive Remediation |
| Active Control ConditionThe active control condition is a structured, learning-based program designed to match the nCCR intervention in terms of duration, computer use, audiovisual engagement, and participant contact with research staff. | Behavioural | Active Comparison Control |
Primary outcome
Assess whether nCCR training produces change in subjective cognitive complaints breast cancer survivors with CRCI.
Time frame: 6-weeks
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.
1 secondary outcome
Assess whether 6-weeks of nCCR training produces change in cognitive performance on neuropsychological measures in breast cancer survivors with CRCI.
Time frame: 6-weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Vega Lab WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer N Vega, PhD principal investigator
University of Massachusetts, Worcester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuroplasticity-based Computerized Cognitive Remediation in people with Chemo-brain and Chemotherapy-Related Cognitive Impairment, run by University of Massachusetts, Worcester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess whether nCCR training produces change in subjective cognitive complaints breast cancer survivors with CRCI. (time frame: 6-weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.