Chemotherapy for Cognitive Impairment in Breast Cancer
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Massachusetts General Hospital
Must not be taking: Antipsychotics, ECT
Disqualifiers: Metastatic CNS disease, Schizophrenia, Substance abuse, others
No Placebo Group
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.
12345Is 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.
678910How 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.
1691112Eligibility 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.
+7 more
Trial 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
Participant Groups
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.
3Treatment groups
Active Control
Group I: ARM 1Active Control3 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 2Active Control3 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 3Active Control3 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Massachusetts General HospitalBoston, MA
Massachusetts General Hospital/North Shore Cancer CenterSalem, MA
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Who Is Running the Clinical Trial?
Massachusetts General HospitalLead Sponsor
References
Therapies for Cognitive Deficits Associated With Chemotherapy for Breast Cancer: A Systematic Review of Objective Outcomes. [2022]To systematically review evidence of treatments for cognitive impairments experienced by at least 20% of all women who undergo chemotherapy for breast cancer.
The effect of chemotherapy on subjective cognitive function in younger early-stage breast cancer survivors treated with chemotherapy compared to older patients. [2020]To evaluate the impact of chemotherapy on subjective cognitive functioning according to age in a large cohort of breast cancer patients.
French version of the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) version 3. [2021]Impairment of cognitive function, a common complaint in patients receiving chemotherapy, is usually measured through neuropsychological tests. Patient self-evaluation of cognitive difficulties is an important complement to those tests. The Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) is a self-report questionnaire with potential to be used in standard clinical practice as a tool for evaluating patient's cognitive function before, during, and after chemotherapy. The purpose of our study was to conduct linguistic validation of the French version of the FACT-Cog.
Multifaceted end points in brain tumor clinical trials: cognitive deterioration precedes MRI progression. [2022]Current treatments for brain cancer have, for the most part, equivocal survival benefit. However, clinical trials of new anticancer agents do not adequately assess potential clinical benefits for patient function other than survival and time to tumor progression. We evaluated 56 patients with recurrent brain tumors who were recruited on phase 1 and phase 2 clinical trials and given assessments of cognitive function, quality of life (QOL), and ability to perform activities of daily living (ADL) prior to receiving treatment and at intervals coinciding with MRI scans, generally monthly. Meaningful change on the cognitive and functional assessments was determined by the reliable change index. Cognitive or functional deterioration was then used as a time-dependent covariate in a Cox proportional hazards regression model with tumor progression, as defined by standard criteria, as the end point. Cognitive deterioration occurred 6 weeks prior to radiographic failure (median 7.4 weeks vs. 13.4 weeks). In contrast, median time for QOL to deteriorate was not achieved. Median time for instrumental ADL to decline was 43 weeks, long after tumor progression. For patients with brain cancer, brain function began to worsen before MRI evidence of tumor progression. QOL and ADL function were not strongly tied to cognitive decline or to time to tumor progression, suggesting that these measures may not be sufficiently sensitive to change in clinical trials of new anticancer agents, although they are important measures in terms of patient care. This study also demonstrates the feasibility of performing neurocognitive testing in this patient population. New drugs that slow the cognitive decline of brain tumor patients may be of clinical benefit regardless of the impact on overall survival.
Assessing cognitive dysfunction in breast cancer: what are the tools? [2019]The goal of adjuvant chemotherapy in the treatment of breast cancer is to reduce recurrence and mortality. With respect to quality of life and morbidity, however, such treatments come at a cost. Decreased cognitive functioning, development of fatigue, and mood alterations are common during chemotherapy and persist after its conclusion as evidenced by subjective self-reports and objective neurocognitive performance records. Few efforts, however, have used standardized neuropsychological measures, and no study has empirically selected those measures that best distinguish women in active chemotherapy from those who have previously completed it. Perhaps the most glaring deficit in the literature is that no study has used baseline data to track individual neurocognitive changes across treatment phases and after completion. This article provides an overview of the field of neuropsychology and the cognitive domains theorized to be affected by chemotherapy and the measures typically used, including validated computerized tests, which are tools for future studies; briefly summarizes existing research on the cognitive effects that chemotherapy has on breast cancer patients; compares data resulting from an ongoing pilot study of the cognitive performance of women actively undergoing anthracycline-containing chemotherapy with that of women 6-12 months post chemotherapy completion; and provides a preliminary analysis of the relationship between cognitive and emotional functioning. Future uses of these data to refine the ideal tools that efficiently, accurately, and validly detect short-term and persistent chemotherapy effects are proposed.
The impact of adjuvant therapy for breast cancer on cognitive function: current evidence and directions for research. [2019]Available evidence supports the hypothesis that adjuvant chemotherapy for breast cancer can produce cognitive deficits, and that these deficits may have a significant impact on patients' quality of life. Studies have generally compared the results of a variety of cognitive measures performed following treatment to standardized population-based norms or to cancer patients who received local therapy, rather than to the individual's baseline level of functioning. Several longitudinal studies are in progress or in the planning stages to better quantify and understand the incidence and impact of cognitive effects of adjuvant chemotherapy, and to identify possible susceptibility factors in subgroups. Although the neurocognitive changes appear to be subtle, there may be enough data to consider discussing the possibility of cognitive dysfunction as an adverse effect when assessing the risks and benefits of adjuvant chemotherapy. Likewise, as the aromatase inhibitors are increasingly given to larger numbers of women in the adjuvant setting, it will be important to understand the cognitive impact of estrogen deprivation. Finally, there is interest in examining supportive pharmacologic or behavioral measures that might prevent or decrease cognitive effects in this setting. Herein, the data on cognitive changes associated with chemotherapy for breast cancer, current and future research directions, as well as possible treatments are reviewed.
Cognitive Effects and Depression Associated With Taxane-Based Chemotherapy in Breast Cancer Survivors: A Meta-Analysis. [2021]Purpose: This meta-analysis provides a longitudinal assessment of depression and cognitive impairment induced by taxane-based chemotherapy in women with breast cancer after 6 months of treatment. We highlighted the incidence and prevalence, the cognitive pattern in neuropsychological studies, and the relationship between chemotherapy-induced cognitive impairment and different risk factors. We estimated the effect sizes on each cognitive domain and differentiated effect sizes by each method of comparison of effects (i.e., baseline data, or control groups). Methods: The databases MEDLINE and Embase were searched for publications about taxane-related cognitive changes in patients with breast cancer published from 1980 to 2019. Cross-sectional and self-reported outcomes studies were excluded except for the depression item. Included studies were assessed for risk of bias with the Newcastle-Ottawa Scale. We estimated effect sizes for each cognitive domain and differentiated effect sizes by each method of comparison of effects. The review is reported in compliance with the PRISMA Statement; it was registered prospectively in PROSPERO as CRD42020163255. Results: Eleven studies meeting the criteria were analyzed, which resulted in a sample of 1,057 patients with breast cancer who received chemotherapy including 820 patients (77%) who received taxane-based chemotherapy. Attention and concentration, depression, and executive function domains had significant chemotherapy-induced impairment across all comparison types. Statistically significant improvement was found in language and verbal memory when comparing chemotherapy patients' test scores with baseline or matched controls. Taxane-based chemotherapy had a non-significant effect on processing speed, visual memory, visuospatial, and motor function domains. Conclusions: The occurrence of chemotherapy-induced cognitive impairment 6 months or more after the course of treatment in people with breast cancer is frequent in the domains of attention, executive function, and depression. Other domains appear stable or improve with time after treatment cessation.
Chemotherapy and cognitive impairment: An animal model approach. [2018]A substantial number of cancer survivors who undergo chemotherapy report cognitive disturbances that severely limit daily function (chemobrain). Despite supportive neuropsychological evidence, there is controversy over whether cognitive impairment is caused by the chemotherapy or is the result of potentially confounding factors that include the disease itself, age, and psychological stress. Our research program, conducted on rodents, has confirmed that a range of cognitive processes, mediated in particular by hippocampal and prefrontal brain regions, are affected by anticancer drugs in combination with tumor development and that many of the effects are long lasting. This work has also provided evidence of protective factors (cognitive reserve, physical exercise, environmental enrichment) and the potential of pharmacological treatment (donepezil) interventions in reducing these effects. (PsycINFO Database Record
Cognitive impairment associated with chemotherapy for cancer: report of a workshop. [2022]Cognitive dysfunction may occur in some patients who receive chemotherapy. We provide a summary of an April 2003 workshop on this topic, that included medical oncologists, radiologists, clinical and experimental psychologists, and patient advocates. Current studies indicate that cognitive deficits are often subtle, although they are observed consistently in a proportion of patients, may be durable, and can be disabling. Deficits have been observed in a range of cognitive functions. Underlying mechanisms are unknown, although preliminary studies suggest there may be genetic predisposition and that cognitive impairment may be accompanied by changes in the brain detectable by neuroimaging. The following priorities were established for future research: (1) large-scale clinical studies that use both a longitudinal design and concurrent evaluation of patients with cancer who do not receive chemotherapy-such studies should address the probability and magnitude of cognitive deficits, factors that predict them, and underlying mechanisms; (2) exploration of discrepancies between subjective reports of cognitive dysfunction and the objective results of cognitive testing; (3) studies of cognitive function in patients receiving treatment for diseases other than breast cancer, and in both men and women, to address the hypothesis that underlying mechanisms relate to changes in serum levels of sex hormones and/or to chemotherapy-induced menopause; (4) development of interventions to alleviate these problems; and (5) development of animal models and the use of imaging techniques to address mechanisms that might cause cognitive impairment associated with chemotherapy.
Chemotherapy altered brain functional connectivity in women with breast cancer: a pilot study. [2021]Adjuvant chemotherapy is associated with improvements in long-term cancer survival. However, reports of cognitive impairment following treatment emphasize the importance of understanding the long-term effects of chemotherapy on brain functioning. Cognitive deficits found in chemotherapy patients suggest a change in brain functioning that affects specific cognitive domains such as attentional processing and executive functioning. This study examined the processes potentially underlying these changes in cognition by examining brain functional connectivity pre- and post-chemotherapy in women with breast cancer. Functional connectivity examines the temporal correlation between spatially remote brain regions in an effort to understand how brain networks support specific cognitive functions. Nine women diagnosed with breast cancer completed a functional magnetic resonance imaging (fMRI) session before chemotherapy, 1 month after, and 1 year after the completion of chemotherapy. Seed-based functional connectivity analyses were completed using seeds in the intraparietal sulcus (IPS) to examine connectivity in the dorsal anterior attention network and in the posterior cingulate cortex (PCC) to examine connectivity in the default mode network. Results showed decreased functional connectivity 1 month after chemotherapy that partially returned to baseline at 1 year in the dorsal attention network. Decreased connectivity was seen in the default mode network at 1 month and 1 year following chemotherapy. In addition, increased subjective memory complaints were noted at 1 month and 1 year post-chemotherapy. These findings suggest a detrimental effect of chemotherapy on brain functional connectivity that is potentially related to subjective cognitive assessment.
Longitudinal Trajectory and Characterization of Cancer-Related Cognitive Impairment in a Nationwide Cohort Study. [2022]Cancer-related cognitive impairment (CRCI) is an important clinical problem in patients with breast cancer receiving chemotherapy. Nationwide longitudinal studies are needed to understand the trajectory and severity of CRCI in specific cognitive domains.
Breast cancer chemotherapy-related cognitive dysfunction. [2019]Cognitive side effects of systemic chemotherapy have become an increasing concern among breast cancer survivors, their families, and health care professionals. A growing body of research supports the hypothesis that chemotherapy can produce long-term cognitive changes in at least a subgroup of cancer survivors. We review evidence implicating systemic chemotherapy as the cause of cognitive changes; describe the limitations due to lack of longitudinal studies and gaps in knowledge (ie, no clear mechanism by which chemotherapy can produce cognitive changes has been proposed); discuss possible factors like age, intelligence quotient/education, and psychological, genetic, and hormonal factors that might increase risk for chemotherapy-induced cognitive changes; and outline future directions for research. Such future research includes large-scale, longitudinal studies of pretreatment neuropsychological assessments, use of imaging techniques and the development of animal models to study the mechanisms of chemotherapy-induced changes in cognitive functioning, and the development of interventions to prevent or reduce the negative cognitive effects of chemotherapy