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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04290897.
PRIMARY OBJECTIVE:
I. To examine the effectiveness of anhydrous enol-oxaloacetate (oxaloacetate) in reducing cognitive complaints in breast cancer patients over the course of 8 weeks.
SECONDARY OBJECTIVES:
I. To assess the tolerability of oxaloacetate.
II. To examine whether oxaloacetate has an effect on the neurocognitive domain of executive function.
III. To examine whether oxaloacetate has an effect on patient reported fatigue, insomnia, and depressive symptoms.
IV. To collect blood for assessment of inflammatory markers and glutamate levels.
OUTLINE:
Patients receive anhydrous enol-oxaloacetate orally (PO) twice daily (BID) for 8 weeks in the absence of worsening symptoms or unacceptable toxicity.
After completion of study treatment, patients are followed up at 4 weeks.
Trial PhasePhase II
Trial Typesupportive care
Lead OrganizationUCLA / Jonsson Comprehensive Cancer Center
Principal InvestigatorPatricia A. Ganz