Oxaloacetate for Cognitive Function in Breast Cancer Survivors
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Female
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Jonsson Comprehensive Cancer Center
No Placebo Group
Prior Safety Data
Approved in 1 jurisdiction
Trial Summary
What is the purpose of this trial?This phase II trial studies how well oxaloacetate works in reducing cognitive complaints in stage 0-IIIA breast cancer survivors. Oxaloacetate is a natural substance found in the body and is available as a nutritional supplement. Giving oxaloacetate may reduce inflammation in the brain that could be contributing to cognitive complaints seen after cancer treatments.
Do I have to stop taking my current medications for this trial?Yes, you may need to stop taking certain medications. The trial excludes participants taking chronic medications that interfere with cognitive functioning, such as those for sleep, anxiety, or pain, as well as illicit drugs or cannabis.
Is the drug Anhydrous Enol-oxaloacetate a promising treatment for improving cognitive function in breast cancer survivors?Yes, Anhydrous Enol-oxaloacetate is a promising drug because it may help improve cognitive function in breast cancer survivors who often experience memory and attention problems after chemotherapy.14789
What safety data exists for oxaloacetate in treating cognitive function in breast cancer survivors?The provided research does not contain any safety data on oxaloacetate or its variants (Anhydrous Enol-oxaloacetate) for treating cognitive function in breast cancer survivors. The studies focus on cognitive dysfunction related to chemotherapy and the potential protective effects of erythropoietin, but do not mention oxaloacetate.12367
What data supports the idea that Oxaloacetate for Cognitive Function in Breast Cancer Survivors is an effective treatment?The available research does not provide specific data on the effectiveness of Oxaloacetate for improving cognitive function in breast cancer survivors. However, it highlights the cognitive challenges faced by survivors after chemotherapy and hormonal therapy, such as memory and attention issues. Other treatments like aerobic exercise and various pharmacotherapies, including stimulants and mood stabilizers, are being explored for their potential benefits in addressing these cognitive issues. Without direct evidence for Oxaloacetate, it's unclear how it compares to these other treatments.13578
Eligibility Criteria
This trial is for women who've had early-stage breast cancer (stage 0-IIIa), are 12+ months post-treatment but within 5 years of diagnosis, and have cognitive complaints. They must be able to complete surveys in English, sign consent, use contraception if necessary, and not have active cancer or serious illnesses.Inclusion Criteria
I don't have active breast cancer or any serious chronic illness.
Exclusion Criteria
I do not have any serious illnesses or social situations that would stop me from following the study's requirements.
I am not pregnant or breastfeeding.
I am not on medications that affect my thinking, like those for sleep or pain.
Participant Groups
The study tests oxaloacetate's effectiveness in reducing cognitive issues after breast cancer treatment. Participants will take this natural supplement over an 8-10 week period and answer questionnaires to assess changes in their cognitive function.
1Treatment groups
Experimental Treatment
Group I: Supportive care (anhydrous enol-oxaloacetate)Experimental Treatment2 Interventions
Patients receive anhydrous enol-oxaloacetate PO BID for 8 weeks in the absence of worsening symptoms or unacceptable toxicity.
Anhydrous Enol-oxaloacetate is already approved in United States for the following indications:
🇺🇸 Approved in United States as Anhydrous Enol-oxaloacetate for:
- None approved; Investigational for glioblastoma multiforme, amyotrophic lateral sclerosis, Alzheimer's disease, and cognitive complaints in breast cancer survivors
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
UCLA / Jonsson Comprehensive Cancer CenterLos Angeles, CA
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Who is running the clinical trial?
Jonsson Comprehensive Cancer CenterLead Sponsor
MetVital, Inc.Industry Sponsor
Breast Cancer Research FoundationCollaborator
References
Cognitive function after systemic therapy for breast cancer. [2005]An underinvestigated area of breast cancer survivorship involves the possible impairment of cognitive function following adjuvant chemohormonal therapy. Numerous reports of disturbing and disruptive changes in short- and long-term memory, attention span, concentration, and language skills have been made by breast cancer patients who have received chemotherapy. This article reviews the four published studies that have documented cognitive dysfunction following adjuvant chemohormonal therapies commonly used in breast cancer. The studies describe a subset of approximately one-third of participants who experienced long-term cognitive impairment. Patient- and treatment-related factors that may influence cognitive function are outlined. The impact of these cognitive impairments on the individual breast cancer survivor's quality of life is discussed, as is the potential overall impact of this research on future adjuvant therapy. The need for a prospective longitudinal study documenting the neuropsychological sequelae of adjuvant chemohormonal therapy is emphasized.
Effects of epoetin alfa on cognitive function, mood, asthenia, and quality of life in women with breast cancer undergoing adjuvant chemotherapy. [2019]Several recently published studies describe moderate to severe cognitive dysfunction in breast cancer survivors who were treated with adjuvant chemotherapy 1-5 years before undergoing extensive neuropsychological testing. While these studies are hypothesis-generating and preliminary given their small size and retrospective nature, they consistently suggest that between approximately 15% and 25% of chemotherapy-treated breast cancer patients will have evidence of cognitive dysfunction some years after chemotherapy, compared to about 10% of breast cancer survivors who did not receive chemotherapy. Recent preclinical data strongly suggest that erythropoetin is a potent, endogenous neuroprotective agent that prevents neuronal apoptosis from a variety of insults including hypoxia, trauma, subarachnoidal hemorrhage, and encephalitis. Erythropoietin also appears to enhance learning in a mouse spatial learning maze model. We have conducted a pilot study of epoetin alfa versus placebo in early-stage breast cancer patients who received standard adjuvant anthracycline-based chemotherapy to determine the feasibility of administering standardized neurocognitive assessment tests in the oncology practice setting in order to understand whether the Executive Interview 25 test can detect the subtle cognitive impairment in verbal fluency, attention, and short-term memory observed with chemotherapy, and to assess whether epoetin alfa-treated patients have less evidence of cognitive dysfunction during and 6 months after chemotherapy compared with control-treated patients. We report here the preliminary results of this pilot clinical trial.
The influence of erythropoietin on cognitive function in women following chemotherapy for breast cancer. [2015]Cognitive dysfunction is a potential side effect of chemotherapy, and erythropoietin might be protective. A previously reported study compared quality-of-life in women undergoing chemotherapy for breast cancer who were randomized to receive epoetin-alpha or standard care. Here, we report a non-randomized sub-study in which cognitive function of participants was evaluated at 12-30 months after chemotherapy.
Neuropsychological performance in survivors of breast cancer more than 20 years after adjuvant chemotherapy. [2013]Adjuvant chemotherapy for breast cancer can have adverse effects on cognition shortly after administration. Whether chemotherapy has any long-term effects on cognition is largely unknown, yet it becomes increasingly relevant because of the widespread use of chemotherapy for early-stage breast cancer and the improved survival. We investigated whether cyclophosphamide, methotrexate, and fluorouracil (CMF) chemotherapy for breast cancer is associated with worse cognitive performance more than 20 years after treatment.
Emerging pharmacotherapy for cancer patients with cognitive dysfunction. [2022]Advances in the diagnosis and multi-modality treatment of cancer have increased survival rates for many cancer types leading to an increasing load of long-term sequelae of therapy, including that of cognitive dysfunction. The cytotoxic nature of chemotherapeutic agents may also reduce neurogenesis, a key component of the physiology of memory and cognition, with ramifications for the patient's mood and other cognition disorders. Similarly radiotherapy employed as a therapeutic or prophylactic tool in the treatment of primary or metastatic disease may significantly affect cognition. A number of emerging pharmacotherapies are under investigation for the treatment of cognitive dysfunction experienced by cancer patients. Recent data from clinical trials is reviewed involving the stimulants modafinil and methylphenidate, mood stabiliser lithium, anti-Alzheimer's drugs memantine and donepezil, as well as other agents which are currently being explored within dementia, animal, and cell culture models to evaluate their use in treating cognitive dysfunction.
Persistent cognitive changes in breast cancer patients 1 year following completion of chemotherapy. [2019]Numerous studies have shown that there are acute cognitive side-effects of chemotherapy for breast cancer. Presumably, patients are more concerned about chronic treatment effects. This report from a prospective longitudinal study compares cognitive functioning in 56 breast cancer patients 1 year after chemotherapy to that of 56 healthy individuals. Neuropsychological test scores were combined into verbal memory, visual memory, working memory, and processing speed scores, as well as an overall summary score, and analyzed using multi-level growth modeling. Frequency of cognitive decline was assessed using regression-based change scores. There was significant rebound in the overall summary score from end of treatment to 1-year follow-up as well as a substantial reduction in the frequency of cognitive decline. However, more than one-third of the breast cancer patients who showed cognitive decline immediately following completion of chemotherapy showed persistent cognitive decline 1 year later. Furthermore, recovery was not seen in all cognitive domains. In fact, the rebound was significant only for working memory. Longer multi-site studies are recommended to explore the risk factors for and the permanence of these longer-term cognitive effects.
Cognitive Deficits in Breast Cancer Survivors After Chemotherapy and Hormonal Therapy. [2015]Adjuvant treatments, specifically chemotherapy and hormonal therapy, have dramatically increased breast cancer survival, resulting in increased attention to the residual effects of treatment. Breast cancer survivors (BCS) frequently report that cognitive deficits are a particular source of distress, interfering with many aspects of quality of life. The literature on neuropsychological performance measures in BCS supports the reality of subtle cognitive deficits after both chemotherapy and hormonal therapy. This premise is supported by recent imaging studies, which reveal anatomical changes after chemotherapy as well as changes in patterns of neural activation while performing cognitive tasks. This review suggests that, even when performance on neuropsychological performance measures is within normal limits, BCS may be using increased cognitive resources in the face of reduced cognitive reserve. Potential interventions for cognitive deficits after adjuvant therapy include prescriptions for healthy living, pharmacotherapy, complementary therapy, and cognitive remediation therapy directed toward specific cognitive deficits or a combination of several strategies.
Effect of aerobic exercise on cancer-associated cognitive impairment: A proof-of-concept RCT. [2019]Change in cognitive ability is a commonly reported adverse effect by breast cancer survivors. The underlying etiology of cognitive complaints is unclear and to date, there is limited evidence for effective intervention strategies. Exercise has been shown to improve cognitive function in older adults and animal models treated with chemotherapy. This proof-of-concept randomized controlled trial tested the effect of aerobic exercise versus usual lifestyle on cognitive function in postmenopausal breast cancer survivors.
Combined Exercise and Game-Based Cognitive Training Intervention: Correlative Pilot Study of Neurotrophic and Inflammatory Biomarkers for Women With Breast Cancer. [2023]Interventions that increase neuroprotective factors and/or decrease inflammatory biomarkers may be effective in improving cognitive function for cancer survivors. Concurrent investigation of potential mechanism(s) to fully understand and refine effective interventions is needed.