Oxaloacetate for Cognitive Function in Breast Cancer Survivors

Overseen By Barbara Kahn-Mills

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Jonsson Comprehensive Cancer Center

Must not be taking: Sleep medications, Anxiety medications, Narcotics, Cannabis

Disqualifiers: Chronic illness, Psychiatric condition, Pregnancy, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

24 Participants Needed

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 need to stop my current medications to join the trial?

The trial does not specify if you need to stop all current medications, but you cannot take medications that interfere with cognitive functioning, like those for sleep, anxiety, or pain. You can continue endocrine or HER-2 targeted therapy if you are on them.

How is the drug Anhydrous Enol-oxaloacetate unique for cognitive function in breast cancer survivors?

Anhydrous Enol-oxaloacetate is unique because it is being explored specifically for its potential to improve cognitive function in breast cancer survivors, a novel approach compared to traditional treatments like chemotherapy and hormonal therapy, which often focus on cancer itself rather than cognitive side effects. ^{1 2 3 4 5}

Research Team

Patricia A. Ganz

Principal Investigator

UCLA / Jonsson Comprehensive Cancer Center

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

Ability to understand and the willingness to sign a written informed consent document

Ability to complete evaluation surveys in English

I was diagnosed with early stage breast cancer, finished initial treatments over a year ago, but it's been less than 5 years since my diagnosis.

Exclusion Criteria

I do not have any serious illnesses or social situations that would stop me from following the study's requirements.

I have a serious health or mental condition that could affect my participation in the study.

Participants may not be receiving any other investigational agents

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive anhydrous enol-oxaloacetate orally twice daily for 8 weeks

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Anhydrous Enol-oxaloacetate

Trial Overview 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.

Participant Groups

Group I: Supportive care (anhydrous enol-oxaloacetate) Experimental Treatment 2 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

Who Is Running the Clinical Trial?

Jonsson Comprehensive Cancer Center

Lead Sponsor

Trials

373

Recruited

35,200+

MetVital, Inc.

Industry Sponsor

Trials

2

Recruited

100+

Breast Cancer Research Foundation

Collaborator

Trials

79

Recruited

40,500+

Findings from Research

Breast cancer survivors often experience cognitive deficits after chemotherapy and hormonal therapy, which can significantly impact their quality of life, despite neuropsychological tests showing normal performance levels.

Imaging studies indicate that these cognitive issues may be linked to anatomical changes in the brain and altered neural activation patterns, suggesting a need for targeted interventions like cognitive remediation therapy and healthy lifestyle prescriptions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Deficits in Breast Cancer Survivors After Chemotherapy and Hormonal Therapy. Frank, JS., Vance, DE., Triebel, KL., et al.[2015]

Approximately one-third of breast cancer survivors who underwent adjuvant chemohormonal therapy reported long-term cognitive impairments, affecting memory, attention, and language skills.

The article highlights the need for further research, including prospective longitudinal studies, to better understand the neuropsychological effects of these therapies and their impact on survivors' quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive function after systemic therapy for breast cancer. Olin, JJ.[2005]

The combined exercise and game-based cognitive training intervention for breast cancer survivors led to a significant increase in insulin-like growth factor 1 (IGF-1) levels, which may be linked to improvements in cognitive function, as indicated by neurocognitive test performance.

The study highlights the feasibility of using fingerstick bloodspot samples for biomarker research, making it easier to conduct studies in various settings, including during pandemic restrictions, while minimizing participant discomfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined Exercise and Game-Based Cognitive Training Intervention: Correlative Pilot Study of Neurotrophic and Inflammatory Biomarkers for Women With Breast Cancer. Myers, J., Pathak, HB., He, J., et al.[2023]

Women who underwent adjuvant CMF chemotherapy for breast cancer showed significantly worse cognitive performance over 20 years later compared to women without a cancer diagnosis, particularly in areas like memory, processing speed, and executive functioning.

Despite experiencing fewer symptoms of depression, these survivors reported more memory complaints, indicating that cognitive deficits from chemotherapy can persist long after treatment has ended.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuropsychological performance in survivors of breast cancer more than 20 years after adjuvant chemotherapy. Koppelmans, V., Breteler, MM., Boogerd, W., et al.[2013]

A 24-week aerobic exercise program for postmenopausal breast cancer survivors showed a significant improvement in processing speed, with participants completing a cognitive test 14.2 seconds faster compared to those who maintained their usual lifestyle.

While self-reported cognitive function did not show significant improvement, brain imaging revealed functional changes in several regions, suggesting that aerobic exercise may positively influence cognitive processing in cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of aerobic exercise on cancer-associated cognitive impairment: A proof-of-concept RCT. Campbell, KL., Kam, JWY., Neil-Sztramko, SE., et al.[2019]

References

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

Cognitive Deficits in Breast Cancer Survivors After Chemotherapy and Hormonal Therapy. [2015]

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

Cognitive function after systemic therapy for breast cancer. [2005]

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

Combined Exercise and Game-Based Cognitive Training Intervention: Correlative Pilot Study of Neurotrophic and Inflammatory Biomarkers for Women With Breast Cancer. [2023]

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

Neuropsychological performance in survivors of breast cancer more than 20 years after adjuvant chemotherapy. [2013]

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

Effect of aerobic exercise on cancer-associated cognitive impairment: A proof-of-concept RCT. [2019]