Oxaloacetate for the Improvement of Cognitive Complaints in Stage 0-IIIA Breast Cancer Survivors

Launched by JONSSON COMPREHENSIVE CANCER CENTER · Feb 27, 2020

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a natural supplement called oxaloacetate on cognitive complaints in women who have survived early-stage breast cancer (stages 0 to IIIA). Many breast cancer survivors experience difficulties with memory and thinking after their treatment, and this study aims to see if oxaloacetate can help reduce those issues by possibly decreasing inflammation in the brain. Women eligible for the trial must have completed their cancer treatments at least 12 months ago and have significant cognitive complaints, but they should not have any active or recurring cancer.

Participants in the study can expect to take oxaloacetate for 8 to 10 weeks and complete surveys to evaluate their cognitive function. To join, women must be aged 18 or older, able to understand English, and willing to follow study guidelines, including using contraception if they could become pregnant. It's important to note that women who are pregnant, breastfeeding, or have certain serious health issues will not be able to participate. This study offers an opportunity to explore a potential new way to improve brain health after cancer treatment.

Gender

FEMALE

Eligibility 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