Using oxaloacetate to help breast cancer survivors with cognitive issues
A Phase II Single Arm Trial Evaluating the Safety and Efficacy of Anhydrous Enol-Oxaloacetate on Improving Cognitive Complaints in Breast Cancer Survivors
This study is testing if taking oxaloacetate can help breast cancer survivors who have been treated for at least a year feel better mentally and reduce issues like fatigue and sleep problems.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years to 74 Years |
| Sex | Female |
| Sponsor | Jonsson Comprehensive Cancer Center Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT04290897 on ClinicalTrials.gov |
What this trial studies
This phase II trial investigates the effectiveness of oxaloacetate, a natural substance, in reducing cognitive complaints among breast cancer survivors who are at least 12 months post-treatment. Participants will take oxaloacetate orally twice daily for 8 weeks, with assessments of cognitive function, fatigue, insomnia, and depressive symptoms. The study also aims to evaluate the tolerability of the treatment and collect blood samples to analyze inflammatory markers and glutamate levels. Follow-up evaluations will occur 4 weeks after treatment completion.
Who should consider this trial
Good fit: Ideal candidates are women diagnosed with early-stage breast cancer (stage 0 to IIIA) who have significant cognitive complaints and are at least 12 months post-treatment.
Not a fit: Patients with active or recurrent breast cancer or those with serious chronic illnesses may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve cognitive function and quality of life for breast cancer survivors experiencing cognitive complaints.
How similar studies have performed: While the use of oxaloacetate in this context is novel, similar studies targeting cognitive complaints in cancer survivors have shown promise.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women with a diagnosis of early stage breast cancer (stage 0, I, II, IIIa) who are at least 12 months after surgery, chemotherapy, radiation, but may be on endocrine therapy or HER-2 targeted therapy, and not more than 5 years after their breast cancer diagnosis * No evidence of active/recurrent breast cancer or other serious chronic illness * Has significant cognitive complaints, defined as a score of \< 12 on the Patient-Reported Outcomes Measurement Information System (PROMIS) Adult version (v) 2.0 - Cognitive Function 4a * Is geographically accessible, and able to participate in a study of 8-10 weeks duration * Ability to complete evaluation surveys in English * The effects of oxaloacetate on the developing human fetus at the recommended therapeutic dose are unknown. For this reason, women of childbearing potential must agree to use adequate contraception (barrier method of birth control; intrauterine device \[IUD\]; abstinence) prior to study entry and for the duration of study participation. Women of any age who have had their ovaries and/or uterus removed will not be at risk for pregnancy and will not require contraception. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately. Menopausal status will be established as follows: Women who are 55 years or older and who are not menstruating will be considered postmenopausal and not at risk for pregnancy. Women who are less than 55 years old who are menstruating will be considered premenopausal and will require contraception. Women who are less than 55 years with an intact uterus and ovaries who are not menstruating and have not had a menstrual period within the past 2 years will have an follicle-stimulating hormone (FSH) and estradiol measured. If the values are in postmenopausal range the woman will be considered postmenopausal and she will not be considered at risk for pregnancy * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Has another serious or chronic medical or psychiatric condition that contributes to substantial physical or emotional disability that would detract from participating in the planned study * Taking chronic medications that would interfere with cognitive functioning such as medications for sleep, anxiety, narcotics for pain, use of illicit drugs or cannabis * Participants may not be receiving any other investigational agents * History of allergic reactions attributed to compounds of similar chemical or biologic composition to oxaloacetate * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Pregnant or breast-feeding women are excluded from this study because the safety of oxaloacetate in this setting is unknown. A pregnancy test will be performed on all women with an intact uterus and ovaries who are not determined to be postmenopausal
Where this trial is running
Los Angeles, California
- UCLA / Jonsson Comprehensive Cancer Center — Los Angeles, California, United States (Recruiting)
Study contacts
- Principal investigator: Patricia A Ganz — UCLA / Jonsson Comprehensive Cancer Center
- Study coordinator: Barbara Kahn-Mills
- Email: bkahnmills@mednet.ucla.edu
- Phone: 310 825-2520
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.