Chemotherapy for Cognitive Impairment in Breast Cancer

Recruiting at 1 trial location

Overseen By Michael W Parsons, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Must not be taking: Antipsychotics, ECT

Disqualifiers: Metastatic CNS disease, Schizophrenia, Substance abuse, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6-14 months

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how chemotherapy affects thinking and the brain in people with breast cancer. Participants will undergo various assessments, including cognitive tests and brain imaging, to track changes in cognition over time. The trial includes three groups: breast cancer patients receiving chemotherapy, patients not receiving chemotherapy, and healthy participants. Individuals with a new breast cancer diagnosis planning to undergo chemotherapy, or those without chemotherapy plans, might be a good fit, along with healthy individuals.

As an unphased trial, participants contribute to valuable research that may improve future cancer treatments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it mentions that participants with well-controlled conditions like hypertension or diabetes can be included, suggesting that some medications may be allowed.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that chemotherapy can cause thinking and memory problems in breast cancer patients, affecting focus and recall. Studies indicate that up to 75% of patients might experience these issues during treatment. Even after treatment, about 35% of patients may still struggle with thinking and memory. Recovery from these difficulties can take several months to a year. While these effects are common, they should be weighed against the benefits of chemotherapy in treating cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to explore the impact of chemotherapy on cognitive function in breast cancer patients. Unlike current treatments that focus primarily on the cancer itself, this study evaluates the broader effects of chemotherapy, using cognitive, functional, and subjective assessments along with advanced imaging techniques like MRI and PET scans. By comparing treated patients, untreated patients, and healthy controls, researchers hope to understand how chemotherapy might affect the brain and cognitive abilities, potentially leading to more comprehensive care strategies that address both cancer and cognitive health.

What evidence suggests that this trial's treatments could be effective for cognitive impairment in breast cancer?

This trial will compare breast cancer patients treated with chemotherapy to non-treated breast cancer patients and healthy control subjects. Research has shown that chemotherapy can lead to thinking and memory problems, often called "chemobrain," in breast cancer patients. Studies have found that many patients experience these issues during and after treatment. However, about 27% of patients reported better memory six months after finishing chemotherapy. These thinking and memory problems can affect everyday tasks and work, but improvements in cognitive speed have been observed over time. Overall, while chemotherapy can cause these challenges, some patients notice improvements after treatment. ^{1 6 7 8 9}

Who Is on the Research Team?

Michael Parsons, PhD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for women aged 60 or older with a new diagnosis of invasive breast cancer and a life expectancy of at least one year. Participants must be planning to undergo chemotherapy, have good functional status (KPS ≥ 80), and be able to consent. There's also a control group who won't receive chemotherapy.

Inclusion Criteria

I am a woman aged 60 years or older.

I can carry out normal activities with minimal symptoms.

I have been newly diagnosed with invasive breast cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Treatment Assessment

Cognitive, functional, and subjective assessments along with imaging (MRI/PET scans) are conducted before chemotherapy

4 weeks

Treatment

Participants with breast cancer receive chemotherapy treatment

6-14 months

Post-Treatment Assessment

Cognitive, functional, and subjective assessments along with imaging (MRI/PET scans) are conducted after chemotherapy

8-14 months

Follow-up

Participants are monitored for cognitive and brain changes after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive, functional and subjective assessments
• MRI
• PET Scan

Trial Overview The study looks at how chemotherapy affects thinking abilities and brain structure in older adults with breast cancer. It involves cognitive tests, MRI scans, and PET scans to assess changes before and after treatment.

How Is the Trial Designed?

Group I: ARM 1 Active Control 3 Interventions

Breast cancer patients treated with chemotherapy * Cognitive, functional and subjective assessments (Pre and Post Treatment) * Imaging (Pre and Post Treatment) * Magnetic Resonance Imaging (MRI) Scan * Magnetic Resonance Imaging (MRI) Scan / Positron Emission Tomography (PET) Scan

Group II: ARM 2 Active Control 3 Interventions

Non-treated breast cancer patient control * Cognitive, functional and subjective assessments (Post enrollment and 6-14 months later * Imaging (Post Enrollment and at 8-14 months later) * Magnetic Resonance Imaging (MRI) Scan * Magnetic Resonance Imaging (MRI) Scan / Positron Emission Tomography (PET) Scan

Group III: ARM 3 Active Control 3 Interventions

Healthy control subjects * Cognitive, functional and subjective assessments (Post enrollment and 6-14 months later * Imaging (Post Enrollment and at 8-14 months later) * Magnetic Resonance Imaging (MRI) Scan * Magnetic Resonance Imaging (MRI) Scan / Positron Emission Tomography (PET) Scan

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Published Research Related to This Trial

A nationwide study involving 580 breast cancer patients showed significant cognitive decline in visual memory and other cognitive domains from prechemotherapy to 6 months postchemotherapy, indicating that cancer-related cognitive impairment (CRCI) is a persistent issue.

In contrast, 363 control participants did not experience cognitive changes over the same period, highlighting the specific impact of chemotherapy on cognitive function in breast cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Longitudinal Trajectory and Characterization of Cancer-Related Cognitive Impairment in a Nationwide Cohort Study. Janelsins, MC., Heckler, CE., Peppone, LJ., et al.[2022]

Systemic chemotherapy may lead to long-term cognitive changes in some breast cancer survivors, raising concerns among patients and healthcare providers.

There is a need for more longitudinal studies to understand the mechanisms behind these cognitive changes and to identify risk factors, as well as to develop interventions to mitigate these effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breast cancer chemotherapy-related cognitive dysfunction. Ahles, TA., Saykin, AJ.[2019]

Cognitive therapy delivered after chemotherapy shows promise in improving cognitive functions such as verbal memory, attention, and processing speed in women who have undergone treatment for breast cancer.

Medical interventions were found to be ineffective, while restorative and exercise treatments yielded mixed results, highlighting the need for further research into effective cognitive training methods for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapies for Cognitive Deficits Associated With Chemotherapy for Breast Cancer: A Systematic Review of Objective Outcomes. Morean, DF., O'Dwyer, L., Cherney, LR.[2022]

The French version of the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) was validated with 63 cancer patients undergoing chemotherapy, showing it is a reliable tool for self-reporting cognitive abilities.

The FACT-Cog demonstrated high internal consistency across its subscales, indicating that it effectively measures perceived cognitive impairments and their impact on quality of life in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

French version of the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) version 3. Joly, F., Lange, M., Rigal, O., et al.[2021]

Chemotherapy significantly impairs subjective cognitive functioning in breast cancer patients, with the most pronounced effects observed in those under 55 years old, lasting up to 24 months after treatment.

In a study of 715 early-stage breast cancer patients, younger patients reported lower cognitive functioning compared to older patients, indicating that age plays a critical role in how chemotherapy affects cognitive health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of chemotherapy on subjective cognitive function in younger early-stage breast cancer survivors treated with chemotherapy compared to older patients. Gregorowitsch, ML., Ghedri, A., Young-Afat, DA., et al.[2020]

Adjuvant chemotherapy for breast cancer may lead to cognitive deficits that can significantly affect patients' quality of life, with ongoing studies aiming to better quantify these effects and identify susceptible subgroups.

There is a growing interest in understanding the cognitive impact of estrogen deprivation from aromatase inhibitors and exploring supportive measures to mitigate cognitive effects associated with chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of adjuvant therapy for breast cancer on cognitive function: current evidence and directions for research. Rugo, HS., Ahles, T.[2019]

Cognitive dysfunction is a common issue among chemotherapy patients, with subtle but consistent deficits observed in various cognitive functions, which can be long-lasting and disabling.

Future research priorities include conducting large-scale studies to understand the extent and causes of cognitive deficits, exploring the differences between subjective and objective cognitive assessments, and developing interventions to help alleviate these cognitive issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive impairment associated with chemotherapy for cancer: report of a workshop. Tannock, IF., Ahles, TA., Ganz, PA., et al.[2022]

Taxane-based chemotherapy in women with breast cancer frequently leads to cognitive impairments, particularly in attention, executive function, and increased depression, as observed in a meta-analysis of 11 studies involving 1,057 patients.

While significant impairments were noted in certain cognitive domains, improvements were seen in language and verbal memory over time, suggesting that some cognitive functions may stabilize or recover after treatment cessation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Effects and Depression Associated With Taxane-Based Chemotherapy in Breast Cancer Survivors: A Meta-Analysis. Ibrahim, EY., Domenicano, I., Nyhan, K., et al.[2021]

A study involving nine women with breast cancer showed that chemotherapy led to decreased functional connectivity in brain networks related to attention and memory, particularly noticeable one month after treatment.

While some connectivity partially returned to baseline after one year, subjective memory complaints persisted, indicating long-term cognitive effects of chemotherapy on brain functioning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chemotherapy altered brain functional connectivity in women with breast cancer: a pilot study. Dumas, JA., Makarewicz, J., Schaubhut, GJ., et al.[2021]

Research on rodents has shown that chemotherapy can lead to long-lasting cognitive impairments, particularly affecting brain regions like the hippocampus and prefrontal cortex, which are crucial for memory and decision-making.

Protective factors such as cognitive reserve, physical exercise, and environmental enrichment may help mitigate these cognitive effects, and pharmacological treatments like donepezil could also be beneficial in reducing cognitive disturbances in cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chemotherapy and cognitive impairment: An animal model approach. Winocur, G.[2018]

Adjuvant chemotherapy for breast cancer can lead to significant cognitive impairments, fatigue, and mood changes, which may persist even after treatment ends, highlighting the need for better assessment methods.

This study emphasizes the importance of using standardized neuropsychological measures to track cognitive changes in women undergoing chemotherapy, comparing their performance with those who have completed treatment, to better understand the long-term effects of chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing cognitive dysfunction in breast cancer: what are the tools? Freeman, JR., Broshek, DK.[2019]

In a study of 56 patients with recurrent brain tumors, cognitive function began to decline approximately 6 weeks before any visible tumor progression was detected on MRI scans, indicating that cognitive assessments may provide early insights into treatment efficacy.

Quality of life (QOL) and ability to perform daily activities (ADL) were not closely linked to cognitive decline or tumor progression, suggesting that these measures may not be sensitive enough for evaluating new cancer treatments, even though they are crucial for patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multifaceted end points in brain tumor clinical trials: cognitive deterioration precedes MRI progression. Meyers, CA., Hess, KR.[2022]

Citations

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Chemotherapy‐induced cognitive impairment in breast cancer ... Also, 27% of patients reported an improvement in memory at the six‐month follow‐up.

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Cognitive impairment following breast cancer treatments Patients undergoing chemotherapy seemed to have a higher chance of cognitive decline. Summarizing, all systematic reviews found significant ...

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The chemobrain in breast cancer patients: a systematic ... The aim of the study was to determine the incidence of chemobrain in breast cancer patients, define it, and review the various tools used to ...

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Cognitive Stimulation Interventions for Chemotherapy-Related ... Cognitive difficulties are a common and often persistent side effect experienced by many breast cancer patients following chemotherapy, ...

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Cognitive and Return to Work Status After Breast Cancer ... Return to work 2 years after breast cancer diagnosis was associated with higher cognitive speed performances before and after cancer treatment.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7569321/

An Overview on Chemotherapy-induced Cognitive Impairment ... Cognitive impairment is an adverse reaction of cancer chemotherapy and is likely to affect up to 75% of patients during the treatment and 35% of patients ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0065230X22000513

Chemobrain: A review on mechanistic insight, targets and ... In general, 70–75% of patients are estimated to develop cognitive decline, during and after prolonged chemotherapy (Fardell, Vardy, Johnston, & Winocur, 2011).

8. ecancer.org ecancer.org/en/journal/article/1958-the-challenge-of-chemotherapy-related-cognitive-impairment-assessing-and-managing-cognitive-decline-after-cancer-treatment

The challenge of chemotherapy-related cognitive impairment Cancer treatment has been shown to be a risk factor for cognitive decline [2]. This is mainly related to the treatments, with chemotherapy (CT) ...

9. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2785382

Cancer-Related Cognitive Impairment in Patients With a ... Patients who develop cognitive difficulties during the acute phase of breast cancer treatment may require several months to a year for recovery.