Chemotherapy for Cognitive Impairment in Breast Cancer

Recruiting at 1 trial location

Overseen By Edwin Nunez

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

Trial Summary

What is the purpose of this trial?

This research study evaluates the effect of chemotherapy on cognition (thinking) and the brain in people with breast cancer.

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.

What data supports the effectiveness of this treatment for cognitive impairment in breast cancer patients?

The research highlights that cognitive impairments are common in breast cancer patients undergoing chemotherapy, with at least 20% experiencing these issues. While specific data on the effectiveness of the treatment in the trial is not provided, the use of cognitive assessments and patient self-evaluations like the FACT-Cog questionnaire is supported as important tools for evaluating cognitive function during and after chemotherapy. ^{1 2 3 4 5}

Is chemotherapy for breast cancer generally safe for cognitive function?

Chemotherapy for breast cancer can lead to cognitive issues, such as problems with attention and memory, which may last for months after treatment. These effects are often subtle but can impact daily life, and ongoing research is exploring ways to reduce these cognitive changes. ^{6 7 8 9 10}

How does this treatment for cognitive impairment in breast cancer differ from other treatments?

This treatment is unique because it specifically targets cognitive impairments caused by chemotherapy in breast cancer patients, a condition for which there are currently no standard treatments. The research highlights the need for interventions to alleviate cognitive problems, suggesting that this treatment could be a novel approach in addressing these issues. ^{1 6 9 11 12}

Research Team

Michael Parsons, PhD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

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

Therapies for Cognitive Deficits Associated With Chemotherapy for Breast Cancer: A Systematic Review of Objective Outcomes. [2022]

2. Netherlands 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. [2020]

3. Germany pubmed.ncbi.nlm.nih.gov

French version of the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) version 3. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Multifaceted end points in brain tumor clinical trials: cognitive deterioration precedes MRI progression. [2022]

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

Assessing cognitive dysfunction in breast cancer: what are the tools? [2019]

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

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

7. Switzerland pubmed.ncbi.nlm.nih.gov

Cognitive Effects and Depression Associated With Taxane-Based Chemotherapy in Breast Cancer Survivors: A Meta-Analysis. [2021]

8. Canada pubmed.ncbi.nlm.nih.gov

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

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

Cognitive impairment associated with chemotherapy for cancer: report of a workshop. [2022]

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

Chemotherapy altered brain functional connectivity in women with breast cancer: a pilot study. [2021]

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

Longitudinal Trajectory and Characterization of Cancer-Related Cognitive Impairment in a Nationwide Cohort Study. [2022]

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

Breast cancer chemotherapy-related cognitive dysfunction. [2019]