Cognitive Training for Chemobrain

Overseen By Nicole T Nguyen, MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University Medical Center

Must not be taking: Investigational drugs

Disqualifiers: Neurologic, Psychiatric, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

20 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Do I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications. However, you can continue using certain CNS active medications, like antidepressants, if your dosage has been stable for at least 3 months.

What data supports the idea that Cognitive Training for Chemobrain is an effective treatment?

The available research shows that Neuroflex, a type of cognitive training, is being explored as a way to help breast cancer survivors who experience cognitive issues after chemotherapy. While the studies focus on identifying cognitive deficits and changes in brain structure due to chemotherapy, they suggest a need for treatments like Neuroflex. However, there is no direct evidence provided in the research that confirms its effectiveness specifically for chemobrain. Comparatively, other cognitive remediation programs have shown improvements in attention for children treated for cancer, indicating potential benefits for similar cognitive training approaches. ^{1 2 3 4 5}

What safety data exists for cognitive training treatments for chemobrain?

The research provided does not explicitly mention safety data for the cognitive training treatments, including Neuroflex, Education Control Condition, or Neuroplasticity-based Computerized Cognitive Remediation. However, these studies focus on evaluating the efficacy of cognitive training programs in improving cognitive impairments related to chemotherapy. The studies suggest potential benefits in cognitive function, but they do not provide specific safety data or adverse effects related to these interventions. Further research, including Phase 3 clinical trials, is needed to establish long-term safety and effectiveness. ^{1 5 6 7 8}

Is NeuroFlex a promising treatment for chemobrain?

Yes, NeuroFlex is a promising treatment for chemobrain because it aims to improve cognitive issues caused by chemotherapy, which many cancer patients experience. It offers a new way to help breast cancer survivors deal with these cognitive challenges. ^{1 3 8 9 10}

Eligibility Criteria

This trial is for adults aged 35-80 who have had breast cancer and received chemotherapy within the last 1-8 years. They must speak English, report ongoing cognitive issues post-treatment, and be medically stable. Exclusions include significant cognitive impairment or dementia, recent investigational drug use, certain unstable conditions, color blindness, unstable psychiatric disorders, and substance abuse history.

Inclusion Criteria

I am between 35 and 80 years old.

I do not have any unstable health conditions.

I have been diagnosed with breast cancer.

Exclusion Criteria

I do not have any major illnesses that would prevent me from following the study's requirements.

My dose for CNS active medications like antidepressants has been stable for 3 months.

I have never had a severe head injury with lasting brain problems.

Treatment Details

Interventions

• Education Control Condition
• Neuroplasticity-based Computerized Cognitive Remediation

Trial Overview The study tests a computer program designed to improve thinking skills affected by chemotherapy (nCCR) against an educational control condition. Participants will randomly receive either the nCCR treatment or education sessions to compare effectiveness in treating 'chemobrain'.

Participant Groups

Group I: Neuroplasticity-based Computerized Cognitive Remediation Experimental Treatment 1 Intervention

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.

Group II: Education Comparison Control Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

University of Utah

Collaborator

Trials

1,169

Recruited

1,623,000+

Findings from Research

A pilot study involving 21 breast and gynecologic cancer survivors showed that the Neuroflex cognitive enhancement program is feasible and well-accepted, with participants completing an average of 44.5 hours of training and achieving a 100% completion rate.

Participants reported significant improvements in cognitive function, including verbal learning and memory, as well as mood and disability assessments, suggesting that Neuroflex may effectively address chemotherapy-related cognitive impairment (CRCI).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of focused computerized cognitive training (Neuroflex) to improve symptoms in women with persistent chemotherapy-related cognitive impairment. Vega, JN., Newhouse, PA., Conley, AC., et al.[2023]

A novel computerized cognitive assessment battery, the Enformia Cogsuite, effectively identified significant cognitive deficits in breast cancer survivors (N=174) compared to age-matched controls (N=183), particularly in attention, executive function, and memory.

The Cogsuite's sensitivity to subtle cognitive dysfunctions allows for better initial diagnosis and monitoring of cognitive changes in cancer survivors, with the added benefit of remote administration to improve accessibility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel computerized neurocognitive test battery is sensitive to cancer-related cognitive deficits in survivors. Gaynor, AM., Ahsan, A., Jung, D., et al.[2022]

Breast cancer patients who underwent chemotherapy showed significant reductions in gray and white matter volume and density in key brain regions, particularly the frontal and temporal areas, compared to those who did not receive chemotherapy and healthy controls.

These structural brain changes are linked to both subjective and objective cognitive impairments, suggesting that chemotherapy may have lasting effects on brain health and cognitive function in cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alterations in brain structure related to breast cancer and its treatment: chemotherapy and other considerations. McDonald, BC., Saykin, AJ.[2022]

In a study of 180 breast cancer patients, those undergoing chemotherapy (CT+) reported significantly worse perceived cognitive impairment (PCI) compared to those not receiving chemotherapy (CT−), indicating that chemotherapy negatively impacts cognitive function.

Objective measures showed that CT+ patients had decreased cerebral activity in the prefrontal cortex during verbal fluency tasks, supporting the link between chemotherapy and cognitive deficits, particularly in executive functioning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chemotherapy-Related Cognitive Impairment in Patients with Breast Cancer Based on Functional Assessment and NIRS Analysis. Durán-Gómez, N., López-Jurado, CF., Nadal-Delgado, M., et al.[2023]

A pilot study involving 31 off-therapy childhood cancer survivors showed that a cognitive remediation program (CRP) significantly improved attention and concentration in participants, with 21 completing the program and demonstrating better results than the comparison group.

While the CRP was effective in enhancing attentional measures, it did not lead to significant improvements in academic achievement, indicating that further research is needed to assess long-term benefits and applicability to other populations with cognitive impairments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Attentional processes and their remediation in children treated for cancer: a literature review and the development of a therapeutic approach. Butler, RW., Copeland, DR.[2022]

A computerized cognitive training program significantly improved working memory, attention, and processing speed in 68 childhood cancer survivors, with a notable effect size indicating its efficacy.

Neuroimaging results showed that the training led to reduced activation in specific brain areas, suggesting that the cognitive improvements were associated with neuroplastic changes in the brain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computerized Cognitive Training for Amelioration of Cognitive Late Effects Among Childhood Cancer Survivors: A Randomized Controlled Trial. Conklin, HM., Ogg, RJ., Ashford, JM., et al.[2022]

In a study of 167 cancer patients undergoing chemotherapy, a 12-week computer-assisted cognitive rehabilitation program showed a significant improvement in perceived cognitive abilities and working memory compared to other control groups.

Patients in the computer-assisted rehabilitation group also reported better quality of life related to cognition and a reduction in depression symptoms, indicating its potential as a beneficial intervention for managing cancer-related cognitive impairment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive rehabilitation program to improve cognition of cancer patients treated with chemotherapy: A 3-arm randomized trial. Dos Santos, M., Hardy-Léger, I., Rigal, O., et al.[2021]

Chemotherapy in cancer patients is associated with small to medium cognitive impairments, particularly affecting attention, processing speed, verbal memory, and executive control, as evidenced by a review of 14 studies involving adult patients.

Neuroimaging revealed significant structural changes in the brain, including reduced grey matter density and altered white matter integrity, which correlate with cognitive decline, highlighting the need for further research to understand the biological mechanisms behind these changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Longitudinal assessment of chemotherapy-induced changes in brain and cognitive functioning: A systematic review. Li, M., Caeyenberghs, K.[2019]

Neuroimaging techniques, such as MRI and PET, reveal that structural and functional changes in the brain are associated with cognitive impairments in patients undergoing treatment for non-CNS cancers, particularly those receiving chemotherapy.

There is a need for larger, multicenter studies and a standardized approach to better understand cognitive changes and develop targeted interventions, which could lead to personalized treatment strategies for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuroimaging biomarkers and cognitive function in non-CNS cancer and its treatment: current status and recommendations for future research. Saykin, AJ., de Ruiter, MB., McDonald, BC., et al.[2021]

Chemotherapy-induced cognitive dysfunction, commonly referred to as 'chemobrain,' affects up to 78% of cancer patients, significantly impacting their quality of life and cognitive abilities such as memory and attention.

The underlying mechanisms of chemobrain are not fully understood, but increased proinflammatory cytokines and oxidative stress are believed to play key roles, alongside potential effects on neurotransmission and neurogenesis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Four decades of chemotherapy-induced cognitive dysfunction: comprehensive review of clinical, animal and in vitro studies, and insights of key initiating events. Dias-Carvalho, A., Ferreira, M., Ferreira, R., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Use of focused computerized cognitive training (Neuroflex) to improve symptoms in women with persistent chemotherapy-related cognitive impairment. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Novel computerized neurocognitive test battery is sensitive to cancer-related cognitive deficits in survivors. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Alterations in brain structure related to breast cancer and its treatment: chemotherapy and other considerations. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Chemotherapy-Related Cognitive Impairment in Patients with Breast Cancer Based on Functional Assessment and NIRS Analysis. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Attentional processes and their remediation in children treated for cancer: a literature review and the development of a therapeutic approach. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Computerized Cognitive Training for Amelioration of Cognitive Late Effects Among Childhood Cancer Survivors: A Randomized Controlled Trial. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Cognitive rehabilitation program to improve cognition of cancer patients treated with chemotherapy: A 3-arm randomized trial. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Longitudinal assessment of chemotherapy-induced changes in brain and cognitive functioning: A systematic review. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Neuroimaging biomarkers and cognitive function in non-CNS cancer and its treatment: current status and recommendations for future research. [2021]

10. Germany pubmed.ncbi.nlm.nih.gov

Four decades of chemotherapy-induced cognitive dysfunction: comprehensive review of clinical, animal and in vitro studies, and insights of key initiating events. [2022]